October Newsletter

EU REGULATIONS

The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021

To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation introducing substantial changes in the regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. The length of the proposed transition periods depends on the type of device:

• Class D (High Risk Devices): until May 2025 and 2026
• Class C (High to Moderate Risk Devices): until May 2025 and 2026
• Class B (Moderate to Low-Risk Devices): until May 2027
• Class A (Low Risk Devices): until May 2027

Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation | 14 October 2021

The European Commission has proposed Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation (IVDR) to prevent disruption in the supply of these essential healthcare products. The general application date of the Regulation remains 26 May 2022. In particular, the IVD Regulation will apply in full as of 26 May 2022 to CE marked in vitro diagnostic medical devices that do not require the involvement of a notified body (i.e., class A non-sterile devices which represent around 20% of the market) and to ‘new’ in vitro diagnostics (i.e., those not covered by a certificate or a manufacturer’s declaration of conformity issued prior to 26 May 2022).

MDCG: Guidance on classification of medical devices | October 2021

The purpose of this chapter is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements as the classification of medical devices in EU medical device legislation is a risk-based system considering the vulnerability of the human body and the potential risks associated with the devices.

MDCG 2019-6 Rev3: Requirements relating to notified bodies| October 2021

The document presents questions and answers on requirements relating to notified bodies under Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 under following categories:
• Organizational and general requirements
• Resources requirements
• Process requirements

MDCG: Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC | October 2021

The MDCG set up an impromptu task-force regarding the application of transitional provisions laid down in Article 120(3) of Regulation (EU) 2017/745 (MDR), the consequential application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC. The report of the task force was forwarded to all MDCG working groups and MDCG agreed to publish the task-force report as MDCG guidance at its meeting on 19 October 2021.

MDCG: Questions and Answers on repackaging & relabeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2021

The document presents questions and answers about obligations introduced by Article 16(2) to (4) under Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. Article 16(1) of the Regulations outlines cases where the obligations of manufacturers also apply to importers, distributors or other natural or legal persons. Article 16(2) of the Regulations specifies the cases in which certain activities of importers and distributors are not considered modifications of a device, within the meaning of Article 16(1)(c).

Note: Article 16(2), (3) and (4) of the Regulations do not apply to operators subcontracted by the manufacturer (that may also qualify as importers or distributors), who carry out relabelling and/or repackaging activities on behalf and under the control of the manufacturer.

FRANCE

Regulatory developments impacting medical devices that contain cobalt | 01 October 2021

Cobalt, most often alloyed with other metals, is a natural metallic element that is used in the manufacture of many medical devices. As of 1 October 2021, cobalt is classified as a substance: carcinogen 1B, mutagen 2, toxic for reproduction 1B, pursuant to Delegated Regulation 2020/217 of the European Commission but the use of this metal in MDs is not prohibited by this delegated regulation. In accordance with EU MDR 2017/745, devices containing cobalt in a concentration greater than 0.1% by mass fraction (m/m) must now meet the new safety and performance requirements set out in point 10.4 of Chapter II of Annex I. As of 1 October 2021, manufacturers of an MD that contains cobalt must:
• justify the use of cobalt; this can be done, for example, by explaining why another material cannot replace it
• indicate the presence of cobalt by specific labelling on the MD
• provide a leaflet informing of the residual risks

HUNGARY

EU Electronic Application Forms: Electronic application forms eAF 1.25.0.0 version | 19 October 2021

The National Institute of Pharmacy and Nutrition (OGYÉI) informed the marketing authorization holders and applicants about the mandatory use of the electronic application forms eAF 1.25.0.0 starting from 1 November 2021 highlighting implementation of the Medical Device Regulation Art 2(1) of Regulation (EU) 2017/745 as the major change in the version.

ITALY

Medical devices: Update of the Q&A document relating to the requirements of notified bodies| 21 October 2021

The document provides clarifications on the requirements and operating procedures for Notified Bodies, authorized by the Authorities responsible for notified bodies to carry out certification procedures for the purpose of CE marking of medical devices, pursuant to Regulation (EU) 2017/745, which allows their placing on the market, putting into service and free movement within the Community in the territory of the European Union. The update of the Questions and answer document mainly provides clarifications on the services offered by notified bodies in the phases that precede the actual certification process in different ways.

Medical devices, classification guidelines | 15 October 2021

The purpose of this document is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements along with the examples of the risk classes to be attributed to different medical devices in accordance with Annex VIII of Regulation (EU) 2017/745.

AUSTRALIA

Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia | 19 October 2021 

The Australian Government supported working closely with healthcare facilities, state and territory health departments to find ways to increase rapid information sharing about medical device safety and effectiveness following the Senate Inquiry into “the Number of women in Australia who have had transvaginal mesh implants and related matters” which highlighted that the number, range, and complexity of medical devices will increase over time.

Submissions received: Proposed refinements to the requirements for medical device patient information materials | 18 October 2021

The TGA thanked respondents who provided a submission to the public consultation related to the implementation of the requirement for sponsors of implantable medical devices and provided patient information leaflets (PIL) and patient implant cards (PIC) about their medical device. The requirements commenced in late 2018, with a gradual implementation over three years. Guidance documents will be updated to address other concerns raised in the consultation, following a decision from the Government on the proposed refinements.

Essential Principles – consent for noncompliance | 14 October 2021

There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the Therapeutic Goods Act 1989, for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance. In circumstances preventing compliance to one or more parts of an Essential Principle for a limited period, sponsors may request consent to import, supply or export medical devices which do not meet an Essential Principle. For sponsors that are applying for consent to import, supply, or export medical devices that are non-compliant with EP13A, a specific form has been developed.

Classification of active medical devices (including software-based medical devices) | 11 October 2021

The guidance assists manufacturers of active medical devices, including software-based medical devices, to correctly classify their devices as classification rules are applied according to the manufacturer’s intended purpose and considering how the device works. Manufacturers must consider all the classification rules in classifying their medical device. Where more than one rule applies, the device must be classified at the highest applicable level.

Global Medical Device Nomenclature (GMDN) Terms | 06 October 2021

Global Medical Device Nomenclature (GMDN) Terms are an international naming and grouping convention used to identify and consistently describe medical devices. GMDN Terms are made up of a five (5)-digit numeric Code, a Term Name, and a Definition. Devices are taken to be of the same kind if they have the following characteristics:
• the same Sponsor
• the same Manufacturer
• the same classification
• the same GMDN Term
• for Class III medical devices, Class AIMD medical devices and Class 4 IVD devices (other than an immunohematology reagent that is a Class 4 IVD medical device), the same unique product identifier (UPI)

The concept of a kind of medical device forms the basis of such things as
• conformity assessment
• applications for inclusion in the Australian Register of Therapeutic Goods (ARTG)
• custom-made medical device notifications
• registrations for transition
• adverse event notifications

Regulation of software based medical devices | 11 October 2021

The purpose of the guidance is to help manufacturers and sponsors understand how the TGA interprets requirements, and thus indicate how manufacturers and sponsors can comply. Manufacturers and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia, and if necessary, to seek professional advice. It is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.

USA

CDRH Proposed Guidance Development | 26 October 2021 

The Center for Devices and Radiological Health (CDRH) posts two lists of guidance documents each year that it intends to publish during the fiscal year along with an annual retrospective list of previously issued guidance’s for stakeholder review and input. These lists are:
• The A-list: A list of prioritized guidance documents that the Agency intends to publish during the fiscal year.
• The B-list: a list of guidance documents that the Agency intends to publish as resources permit during the fiscal year.

CDRH Proposed Guidance’s for Fiscal Year 2022 (FY2022) | 26 October 2021 

The Center for Devices and Radiological Health (CDRH) posts two lists of guidance documents each year that it intends to publish during the fiscal year along with an annual retrospective list of previously issued guidance’s for stakeholder review and input. These lists are:
• The A-list: A list of prioritized guidance documents that the Agency intends to publish during the fiscal year.
• The B-list: a list of guidance documents that the Agency intends to publish as resources permit during the fiscal year.

Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2022 Proposed Guidance Development | 27 October 2021 

The Food and Drug Administration (FDA) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH) intends to publish in fiscal year (FY) 2022. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders.

Medical Device Reporting (MDR): How to Report Medical Device Problems| 20 October 2021 

Medical Device Reporting (MDR) is one of the Post Market Surveillance (PMS) tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Mandatory reporters (manufacturers, device user facilities, and importers) and voluntary reporters (health care professionals, patients, caregivers, and consumers) are required to submit to the FDA certain types of reports for adverse events, product problems, use errors, product quality issues, and therapeutic failures about medical devices. For voluntary reporting, form FDA 3500 may be used by health professionals or consumers.

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | 20 October 2021 

On 7 November 2013, The FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”.  This updated draft guidance, which supersedes the 7 November 2013 draft guidance, intend to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. This draft guidance is not final nor is it in effect currently.

Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids | 20 October 2021

The Food and Drug Administration (FDA) is proposing to establish a regulatory category for over the counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. FDA propose to:
• define OTC hearing aids and establish applicable requirements
• amend existing rules for consistency with a new OTC category
• repeal the conditions for sale applicable to hearing aids
• amend the existing labeling requirements for hearing aids; and update regulations relating to
decisions on applications for exemption from Federal pre-emption that would become obsolete because of changes to the hearing aid requirements

Surgical Staplers and Staples for Internal Use – Labeling Recommendations Aids | 08 October 2021 

The Food and Drug Administration (FDA) is issued the guidance to provide labelling recommendations for surgical staplers and staples for internal use as malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths. This guidance would help promote the safe and effective use of surgical staplers and staples for internal use by helping manufacturers develop labelling with information about specific risks, limitations, and directions for use of the device.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations | 08 October 2021 

This information collection supports implementation of medical device labelling requirements governed by section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), codified in Agency regulations, and discussed in associated Agency guidance. Medical device labelling regulations in parts 800, 801, 809, and associated regulations in parts 660 and 1040 (21 CFR parts 660, 800, 801, 809, and 1040), prescribe the disclosure of specific information by manufacturers, importers, and distributors of medical devices about themselves and/or the devices, on the label or labelling for the devices, to health professionals and consumers.

Breast Implant Post Market Safety Information | 27 October 2021 

FDA’s post market review of breast implant safety and effectiveness includes:

• Providing input and guidance to manufacturers as they work to meet post-approval study enrolment, follow-up, and objectives.
• Communicating study status and findings to healthcare providers and patients to help inform them of risks associated with breast implants.
• Evaluating breast implant Medical Device Reports (MDRs), especially those related to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and Systemic Symptoms in Women with Breast Implants.
• Assessing all post market reporting requirements associated with the approved PMA, including manufacturing changes, design changes, and annual reports.
When the FDA finds that a manufacturer has significantly violated the FDA’s regulations, the FDA notifies the manufacturer. This notification may be in the form of a Warning Letter.

Labeling for Approved Breast Implants | 27 October 2021 

On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. The FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions and approved new labelling for all legally marketed breast implants that includes:
• Boxed warning.
• Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.
• Updated silicone gel-filled breast implant rupture screening recommendations.
• Device description with a list of specific materials in the device.
• Patient device card.
The FDA expects manufacturers to post the updated device labelling to their websites within the next 30 days and has released updated information on the status of breast implant manufacturer post-approval studies.

FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants | 28 October 2021

The agency issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions.
• the agency issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions
• the agency has approved new labelling for all legally marketed breast implants that includes a boxed warning, a patient decision checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials used in the device and a patient device card
• the FDA released updated information on the status of breast implant manufacturer post-approval studies
These actions will help patients understand the risks and benefits of breast implants and make more informed decisions about their health.

UK

UK, USA, and Canadian regulators identify 10 guiding principles to be addressed when medical devices use AI or machine learning software| 27 October 2021 

The principles cover key elements of GMLP, for example:
• having an in-depth understanding of a model’s intended integration into clinical workflow
• the desired benefits and associated patient risks
• selecting and maintaining training and datasets to be appropriately independent of each other
These guidelines may be used to:
• adopt good practices that have been proven in other sectors
• tailor practices from other sectors so they are applicable to medical technology and the health care
sector
• create new practices specific for medical technology and the health care sector

Consultation on the future regulation of medical devices in the United Kingdom | 26 October 2021

Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices to enable:
• Improved patient and public safety
• Greater transparency of regulatory decision making and medical device information
• Close alignment with international best practice
• More flexible, responsive, and proportionate regulation of medical devices
This consultation looks at how we might change the law around medical devices in the UK by updating the Medical Devices Regulations 2002 (as amended) (UK medical devices regulations). Two webinars aiming
the industry and public were uploaded on the website.

Guidance: Borderlines with medical devices and other products in Great Britain | 01 October 2021

The guidance document covers borderline products with general medical devices as specified in Part II of the Medical Device Regulations 2002 (as amended) and does not cover borderlines with in-vitro diagnostic medical devices or active implantable medical devices.

SWITZERLAND

Patient care in Switzerland at risk| 17 October 2021 

After getting the third country status, Switzerland continues exporting medical products under the new EU regulation but the current situation with imports is alarming. By implementing home-made import barriers, Switzerland is endangering the health care of its own population. Swiss MedTech is therefore urgently calling for changes to the national Medical Devices Ordinance.

PAKISTAN

Draft Guidelines for Imports & Exports of Therapeutic Goods (for Views/Comments of stakeholders) | 25 October 2021 

The guidance document aim to provide an overview of the requirements, procedures and best practices for imports and exports in compliance with the legal and regulatory requirements for all therapeutic goods including finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS), Medical Devices, and Health & OTC Product (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, biochemic and Chinese products) and their raw materials. The guidelines are meant to:
• outline the requirements and documentation for import and export of therapeutic goods
• determine the eligibility, who can import or export therapeutic goods
• elaborate procedure adopted by DRAP for verification and port clearance
• describe the responsibilities of the entities involved in import and export

KAZAKHSTAN

Kazakhstan has introduced the practice of inspection of medical devices before state registration| 18 October 2021 

According to Yerken Dautbayev, Director General of NCELS, special attention is paid to the inspection of domestic manufacturers of medical devices, which should occupy a competitive niche and replace expensive imported medical products, provide domestic health care with high-quality medical products within the framework of the Government’s instructions. Since the beginning of this year, experts from the National Centre for Expertise of Medicines and Medical Devices have conducted inspections for domestic manufacturers of medical products and manufacturers of near and far abroad. The results of the inspection are an integral part of the registration dossier of medical products and are considered when forming the results of the examination.

BRAZIL

Deadline for loading instructions for use ends on 31 October | 04 October 2021 

ANVISA informed about the deadline closure for the loading of instructions for the use of regularized medical devices on 31 October 2021 before the validity of The Collegiate Board Resolution (RDC) 431/2020. The standard states that companies holding records and notifications of these products must upload their instructions for use in the Medical Device Documentary Repository, available in the Regularized Product Consultations section of the Agency’s website and was in force since 1 November 2020. Companies holding records and notifications published or published after the validity of RDC 431/2020 have up to 30 days to arrange the loading of documents in the repository, after the regularization of the product with the Agency.

LITHUANIA

For the attention of companies manufacturing orthopedic medical devices | 28 October 2021 

The State Accreditation Service for Health Activities under the Ministry of Health invites orthopaedic medical device manufacturers to free distance learning for the application of the new Regulation (EU) 2017/745 of the European Parliament and of the Council on the application of medical devices on 18 November 2021, 9.00 on MS Teams by mailing the name of the company or institution intending to participate in distance learning and name and contact details (e-mail, phone number) of the person who will participate in the distance learning on [email protected]

IMDRF DOCUMENTS

Competence and Training Requirements for Auditing Organizations | 20 October 2021 

The document applies to recognized Auditing Organizations conducting audits of a medical device manufacturer for regulatory purposes. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of manufacturers by ensuring that Auditing Organization personnel have the necessary commitment, competence, experience, and training before conducting an audit or undertaking a decision-making function.

Regulatory Authority Assessor Competence and Training Requirements | 20 October 2021 

The document applies to Regulatory Authorities conducting assessments of Auditing Organizations. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of Auditing Organizations by ensuring that Regulatory Authority personnel have the necessary competence and training before conducting an assessment or participating in a decision to recognize an Auditing Organization.

MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization | 20 October 2021 

The purpose of the document is to explain the assessment process and outcomes, including the method to
“grade and manage” nonconformities resulting from recognizing Regulatory Authorities assessment of an
Auditing Organization and, to document the decision process for recognizing an Auditing Organization or
cessation of recognition. This document defines:
• The process and lifecycle for recognizing, maintaining, or ceasing recognition of an Auditing
Organization.
• The process of managing, grading, and closure of assessment nonconformities issued to an Auditing
Organization
• The outcomes of an initial, surveillance, or re-recognition assessment process of an Auditing
Organization

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August Newsletter

EU REGULATIONS

Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 20 August 2021

This guidance is intended to aid notified bodies to implement requirements established by MDR and IVDR about certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. This guidance is also addressed to distributors and importers in respect to their quality management system to be certified by a notified body.

Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 | 18 August 2021

This guidance provides clarification on the meaning of the below mentioned conditions and on the corresponding procedures to be followed by the notified body. For class D devices, Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) establishes the conditions to be applied by the notified body to determine whether it must consult the expert panel on the performance evaluation report of the manufacturer. The conditions are:

  • 1. The absence of common specifications for the class D device in question
  • 2. Where it is also the first certification for that type of device

Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices | 03 August 2021

This guidance document concerns performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746. The content of this guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months. The content may be adapted to take account of changing circumstances and increasing scientific and technical knowledge, as the COVID-19 pandemic continues to evolve.

CROATIA

New Regulation on the Administrative Fee Tariff | 26 August 2021

The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) informs applicants that the Regulation on the Administrative Fee Tariff, has been published in the Official Gazette No. 92/21. The new Regulation, which enters into force on 1 September 2021, abolishes the payment of administrative fees in procedures conducted by HALMED.

BELGIUM

End of submissions for initial CTR pilot files on 14 October 2021 | 05 August 2021

The pilot project for the new Clinical Trial Regulation (CTR) will end when the CTR Regulation enters into force. All initial dossiers under the CTR pilot procedure must be submitted by 14 October 2021. The submission of initial clinical trials under the CTR pilot procedure will still be possible until Thursday 14 October 2021. This allows all initial dossiers to be closed before the regulation comes into force on 31 January 2022. Substantial changes following the pilot procedure will continue to be accepted until the end of the trial or until the transition from the trial to the regulation (which must be made no later than three years after implementation of the CTR).

Updated guidance for submission of clinical trial applications, substantial amendment notifications and end of trial declarations to the FAMHP | 05 August 2021

A new version of the guidance is available, and it supersedes the former circular letter 575. The FAMHP provides more information on the different aspects of clinical trials. The present guidance refers to clinical trials as defined in article 2(a) of Directive 2001/20/EC and does not apply to the submission of clinical trial applications selected for the CTR pilot project.

FINLAND

Laws supplementing EU regulations on medical devices come into force | 04 August 2021

The Acts supplementing the EU regulations on medical devices came into force on 19 July 2021. The Medical Devices Act 719/2021 and the Act on Certain Medical Devices Specified in EU Directives 629/2010 entered into force. In addition, technical amendments have been made to certain other Acts. The aim of the Acts is to improve the safety of patients and medical devices.

FRANCE

Certification of medical devices: GMED is designated as a notified body under the new European regulation | 20 August 2021

GMED, specialized in certification in the medical field, has been designated a notified body (ON) in France, under the new European regulation (EU 2017/745) on medical devices (MD). A notified body assesses and issues the CE marking necessary for the marketing of medical devices in Europe. This designation occurs at the end of the process required by the regulation to ensure the proper functioning of the notified bodies. This demanding process is essential for patient safety. 

The designation of GMED, which was published by the European Commission on 08/07/2020 on the NANDO Notified Bodies Database, will take effect on 09/07/2020, in accordance with Article 42 (11). From this date, GMED will be able to evaluate and certify MDs in accordance with the new European regulation.

ITALY

Medical devices, practical guide for the registration of actors in the European database EUDAMED | 19 August 2021

A short operational guide for voluntary registration in EUDAMED is available. The guide provides operational indications, presented in a simple and intuitive graphic format, intended for manufacturers, agents, importers and manufacturers of systems and procedural kits who want to voluntarily register in EUDAMED. For each phase of registration, the information required by the Ministry of Health for the verification and approval of registration requests is reported.

ECUADOR

Ecuador emerges as a cosmetic power in the international market | 23 August 2021

Entrepreneurs wishing to access the Mandatory Health Notification (NSO) of the National Agency for Regulation, Control and Health Surveillance (ARCSA) for the commercialization of cosmetics, will be able to apply their products to obtain this certification in 25 days. This initiative of the Government of the Meeting, in coordination with Procosmetics and with the aim of having “more Ecuador in the world”, will offer free of charge to microentrepreneurs and artisans of the cosmetic industry, the advice and endorsement of a technical representative with whom they must count for their certification. In this way, they will be able to obtain their NSO nimbly and market their products locally and internationally.

UK 

Register medical devices to place on the market | 24 August 2021 

A pre-existing guidance updated with links of video tutorials and a reference guide for Certificates of Free Sales

Clinical trials applications for Coronavirus (COVID-19) | 03 August 2021 

The National Institute for Health Research (NIHR) are no longer accepting applications for studies to be designated as Urgent Public Health (UPH). However, the MHRA, continues to support COVID-19 trials with ongoing regulatory and scientific input. The MHRA has procedures for rapid scientific advice, reviews and approvals and is supporting manufacturers, researchers, and other regulators.

USA

Medical Device Development Tools (MDDT) | 24 August 2021

The FDA’s Medical Device Development Tools (MDDT) program is intended to facilitate device development and timely evaluation of medical devices, and promote innovation, by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making. 

510(k) Third Party Performance Metrics and Accreditation Status | 18 August 2021

The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA) to improve the efficiency and timeliness of the FDA’s 510(k) process. Under the program, the FDA accredits third parties (or accredited persons, now known as third party review organizations) that are authorized to conduct the primary review of 510(k)s for eligible devices. Under MDUFA IV, the FDA committed to publishing the performance of individual accredited Third Parties with at least five completed submissions on this page (for example, rate of not substantially equivalent (NSE), average number of holds, average time to substantially equivalent (SE)). 

Medical Device User Fee Amendments (MDUFA) | 06 August 2021 

USER FY2021 – Annual Establishment FEES FOR Registration Fee: $5,546 

Other fees for Fiscal Year 2021 (October 1, 2020, through September 30, 2021) are:

APPLICATION TYPESTANDARD FEESMALL BUSINESS FEE (only CDRH Certified small businesses)
510(k) [All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer]$12,432$3,108
513(g)$4,936$2,468
PMA, PDP, PMR, BLA$365,657$91,414
De Novo Classification Request$109,697$27,424
Panel-track Supplement$274,243$68,561
180-Day Supplement$54,849$13,712
Real-Time Supplement$25,596$6,399
BLA Efficacy Supplement$365,657$91,414
30-Day Notice$5,851$2,926
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)$12,798$3,200



Medical Device User Fee Amendments (MDUFA)

USER FEES FOR FY2022 – Annual Establishment Registration Fee: $5,672 

Other fees for Fiscal Year 2022 (October 1, 2021, through September 30, 2022) are:

APPLICATION TYPESTANDARD FEESMALL BUSINESS FEE (only CDRH Certified small businesses)
510(k) [All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer]$12,745$3,186
513(g)$5,061$2,530
PMA, PDP, PMR, BLA$374,858$93,714
De Novo Classification Request$112,457$28,114
Panel-track Supplement$281,143$70,286
180-Day Supplement$56,229$14,057
Real-Time Supplement$26,240$6,560
BLA Efficacy Supplement$374,858$93,714
30-Day Notice$5,998$2,999
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)$13,120$3,280

All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

Accreditation Scheme for Conformity Assessment (ASCA) | 05 August2021

The ASCA Pilot is an accreditation scheme that capitalizes upon the increasingly prominent role that standards play in regulatory science and practice. The voluntary ASCA Pilot is intended to enhance product reviewers’ and device manufacturers’ confidence in medical device testing, which should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes ASCA Pilot testing. Ultimately, the ASCA Pilot is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.

Draft Guidance on Remanufacturing of Medical Devices | 05 August2021

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of June 24, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled “Remanufacturing of Medical Devices.” The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. 

Medical Device Recall Authority |05 August 2021

Section 518(e) of the FD&C Act provides FDA with the authority to issue an order requiring an appropriate person, including manufacturers, importers, distributors, and retailers of a device, if FDA finds that there is reasonable probability that the device intended for human use would cause serious, adverse health consequences or death, to:

  • 1. Immediately cease distribution of such device and
  • 2. Immediately notify health professionals and device-user facilities of the order and to instruct such professionals and facilities to cease use of such device.

FDA will then provide the person named in the cease distribution and notification order with the opportunity for an informal hearing on whether the order should be amended to require a mandatory recall of the device. If, after providing the opportunity for an informal hearing, FDA determines that such an order is necessary, the Agency may amend the order to require a mandatory recall.

CANADA

Regulatory requirements for UV light-emitting products with COVID-19 claims |05 August 2021

UV light-emitting products make various claims related to decontamination and are sold and represented using terms such as disinfection, sterilization, sanitization, decontamination, and cleaning. Decontamination products using UVC that fall under MDD’s scope include those intended for sterilization or high-level disinfection of reusable medical devices used for critical or semi-critical purposes (for example, invasive procedures and personal protective equipment) within a controlled space. These sterilizers and high-level disinfectants are Class II medical devices including Therapeutic devices using UVA/UVB to treat skin conditions. They are used to mitigate or prevent infectious disease in humans and must not deteriorate the performance of the medical device.

Manufacturers of UVC decontamination devices must demonstrate high-level disinfection or sterilization of bacterial spores with an organism that offers a maximum challenge for the chosen technology. A high level of disinfection or sterilization is generally considered to be a minimum 6 log reduction (99.9999%). UV light-emitting decontamination products intended for use in rooms, on environmental surfaces or household products are not considered medical devices. 

AUSTRALIA

Medical devices reforms: Personalized medical devices | 23 August 2021 

A new framework has been introduced to ensure an appropriate level of regulation is applied to Personalised Medical Devices to manage the risk these devices may pose. Prior to 25 February 2021, most Personalised Medical Devices (PMD) met the definition of ‘custom-made’ and were exempt from the requirement to be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported or supplied (though they were subject to other regulatory obligations). Following extensive consultation and liaison with other global regulators, the Therapeutic Goods Administration (TGA) developed a new regulatory framework for PMD to ensure an appropriate level of regulation is applied to PMD to manage the risk they may pose. The new framework came into effect on 25 February 2021, and includes: 

• new definitions for personalised medical devices, including patient-matched and adaptable medical
devices, that reduce the scope of the custom-made medical device exemption
• changes to the conditions of exemption for custom-made medical devices
• new requirements for the inclusion of Medical Device Production System (MDPS) in the ARTG

Regulation of software based medical devices | 19 August 2021

The TGA has implemented reforms to the regulation of software-based medical devices, including software that functions as a medical device. The guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device – SaMD) which came into effect from 25 February 2021. It outlines transition arrangements available for devices that may need to be reclassified. 

Medical device patient information leaflets and implant cards | 13 August 2021 

The guidance refers to requirements set out in clause 13A of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) and provides an overview of:
• the different types of patient information materials (patient information leaflets and patient
implant cards)
• when patient information must be supplied
• how to meet the mandatory requirements for patient information
• best practice requirements for patient information.

Re-classification of software based medical devices | 12 August 2021

All new applications for inclusion of software based medical devices in the Australian Register of Therapeutic Goods (ARTG) must meet these new classification rules. For software that is already on the ARTG, there is a transition period. To access the transition period, you need to notify the TGA before 25 August 2021. The guidance below provides information about the new classification rules for software based medical
devices that:
• provide a diagnosis or screen for a disease or condition
• monitor the state or progression of a disease or condition, or the parameters of a person with a
disease or condition
• specify or recommend a treatment or intervention
• provide therapy through the provision of information

RUSSIA

Applicants submitting documents within the framework of medical device registration procedures | 23 August 2021 

The Federal Service for Supervision in the Field of Healthcare informs about the frequent cases of submission to Roszdravnadzor of documents for registration of medical devices, including amendments to documents contained in the registration dossier, of inadequate quality, including unreadable documents (both in terms of print and font size) and documents containing illegal corrections.

SWITZERLAND

Overview of the obligations of Swiss authorized representatives, importers and distributors | 13 August 2021

The Medical Devices Ordinance (MedDO; SR 812.213) sets out requirements and responsibilities for operators in the medical devices supply chain. The Information sheet outlines the roles and obligations of the Swiss authorized representative, the importer, and the distributor.

BRAZIL

ANVISA simplifies labeling change for sanitizing products | 19 August 2021

Brazilian Health Regulatory Agency (ANVISA) simplified the post-regularization procedure related to the change in labeling in sanitizing products, in accordance with the conditions established in Resolution of the Collegiate Board (RDC) 492/2021. The change implies the automatic approval of layout and label dimensions and inclusion of promotional sayings.

TANZANIA

TMDA ISO 9001:2015 Re-certified | 04 August 2021

TMDA (Tanzania Medicines & Medical Devices Authority) has been re-certified to ISO 9001:2015 standard after being subjected to a comprehensive external quality audit and found to comply with requirements. The ISO 9001:2015 certification will be valid for the next three years from July 2021 depending on successful compliance with annual surveillance audits.

July Newsletter

July Newsletter

EU REGULATIONS

MDCG 2021-23 – Guidance for notified bodies, distributors, and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746| 20 August 2021

Notified bodies providing certifications to certify that the quality management system of the distributor or importer complies with the requirements laid down in the abovementioned Article 16(3), are required to be designated for the type of devices that are subject to activities mentioned in points (a) and (b) of Article 16(2). However, such certification activities to be performed by them are not related to conformity assessment activities carried out to certify manufacturer’s devices according to either Article 52 of the MDR or Article 48 of the IVDR. Therefore, notified bodies need to establish the assessment activities necessary in order to certify the quality management system of a distributor or importer intended to relabel and / or repackage a device. In addition, it is also important to get clarity on the elements to be addressed by distributors and importers in the abovementioned quality management system. This guidance document is mainly focused on activities performed by notified bodies, providing also clarification on the quality management system they are expected to assess.

MDCG 2021-22 – Clarification on “first certificate for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746| 18 August 2021

Notified bodies providing certifications to certify the quality management system of the distributor or importer, are required to be designated for the type of devices that are subject to activities mentioned in points (a) and (b) of Article 16(2). However, such certification activities to be performed by them are not related to conformity assessment activities carried out to certify manufacturer’s devices according to either Article 52 of the MDR or Article 48 of the IVDR. Therefore, notified bodies need to establish the assessment activities necessary in order to certify the quality management system of a distributor or importer intended to relabel and / or repackage a device. In addition, it is also important to get clarity on the elements to be addressed by distributors and importers in the abovementioned quality management system. This guidance document is mainly focused on activities performed by notified bodies, providing also clarification on the quality management system they are expected to assess.

New forms for Notified Bodies in the scope of the MDR and the IVDR | 15 July 2021

Applied for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)

EC MDCG explains EUDAMED requirements for actors not considered manufacturers, Authorized Representatives, or importers under MDR, IVDR | 02 July 2021

The Q&A document aimed at addressing questions relating to the registration in EUDAMED of actors other than manufacturers, authorized representatives, and importers subject to the obligations of Article 31 of Regulation (EU) 2017/745 on medical devices (MDR) and/or Article 28 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It also clarifies the cases where an Actor ID is issued instead of an SRN.

AUSTRIA

July Fee regulations on Clinical trials of Medical devices/Medicinal products | 28 July 2021

Based on the Health and Food Safety Act, Federal Law Gazette I No 63/2002, as modified by Federal Act I No 37/2018, if the notification of a clinical trial of a medical device is submitted at the same time and in the same context as that of a medicinal product by the same applicant, the full fee pursuant to Section XII.1 or XII.2 of the Appendix and 35% of the applicable fee pursuant to Section XI.1 or XI.2 of the Appendix shall be payable.

GERMANY

Application for a decision on the requirement to approve a clinical investigation of a medical device | 7 July 2021

If the regulatory classification of a clinical investigation cannot be clarified, the parties involved in the conduct, approval or monitoring of the clinical investigation may apply for a decision on the approval requirement to the federal higher authority (“Bundesoberbehörde”) in accordance with Section 6 (3) MPDG.

Serious Adverse Events (SAE) reporting obligations according to MDR and MPDG | 6 July 2021

From the date of application of the Regulation (EU) 2017/745 (MDR) on May 26, 2021, the reporting of serious adverse events (SAEs) and device deficiencies must be carried out in accordance with the MDR in conjunction with the Medical Device Law Implementing Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) for all clinical investigations that must be applied for or notified to the federal higher authority (“Bundesoberbehörde”). This also applies to already initiated (ongoing) clinical investigations for which SAEs were previously to be reported to the higher federal authority in accordance with the MPSV(Medizinprodukte-Sicherhetsplanverordnung).

Antigen tests for SARS-CoV-2 | 2 July 2021

The BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) provides a list of antigen tests for professional use for direct pathogen detection of the coronavirus SARS-CoV-2, which are subject of reimbursement claims. The BfArM provides a list according to antigen tests for direct pathogen detection of coronavirus SARS-CoV-2, which are intended by the manufacturer for self-administration (“self-tests”) and, to the knowledge of the BfArM, bear a CE marking or whose first marketing in Germany without a CE marking is currently approved for a limited period by the BfArM according to §11 para.1 MPG (“special approval of the BfArM”).

FRANCE

Information intended for medical and obstetrician gynaecologists, general practitioners, and midwives | 27 July 2021

A letter to healthcare professionals was written by the Ministry of Health recommending withdrawing of the intrauterine devices (IUDs) Ancora or Novaplus in all women for whom the installation was performed before March 2019, whether the IUD was sold alone or with a pose kit in Sethygyn sets.

The DGCCRF and the ANSM publish an information note on the definition of nanomaterials in cosmetics | 27 July 2021

The DGCCRF and the ANSM publish an information note on the definition of nanomaterials in cosmetics and their concerted control actions (investigations, inspections, and laboratory analyses) have highlighted the presence of unauthorized nanomaterials in certain controlled cosmetic products and the absence on the label of the indication in the list of ingredients of certain authorized nanomaterials. The actions undertaken by the ANSM and the DGCCRF have already made it possible to obtain compliance with the regulations or the withdrawal from the French market of several products by the manufacturers concerned, toothpastes, makeup products and solar products.

New European regulation and notice to seekers of scientific advice for any medical device incorporating a medicinal substance | 20 July 2021

Where a medical device incidentally incorporates a medicinal substance, the notified body (responsible for issuing the EU certificate of conformity leading to the CE marking of the device) must call upon a competent medicinal product authority to assess the quality and safety of the active substance, as well as the benefit/risk profile associated with its incorporation into the device. The scientific opinion delivered by the competent authority or by the European Medicines Agency will consider the data on the usefulness of the intake of the substance evaluated by the notified body. Note that this procedure applies to medical devices only when the activity of the drug substance is incidental, that is, when the substance is not responsible for the main activity but acts on the human body by an action ancillary to that of the medical device.

UK MHRA 

Regulator warns against purchasing inaccurate infrared thermometers | 27 July 2021

The public and healthcare professionals are being warned to take care when purchasing infrared thermometers online and to familiarize themselves with warning signs for poor quality products. There has been an increase in the number of unreliable infrared thermometers which are available in the UK. The MHRA is responsible for enforcing the law on medical devices in the UK and has a range of a range of investigatory and enforcement powers to ensure their safety and quality. If suppliers fail to comply with the regulations, then they may be subject to prosecution.

Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland | 09 July 2021

The guidance explains how to obtain a Written Confirmation for each shipment of Active Substances manufactured in Great Britain (England, Wales and Scotland) that is exported to the EEA or Northern Ireland. Importation of active substances into Great Britain (England, Wales and Scotland) without a Written Confirmation is accepted from the following list of countries:
• European Economic Area (EEA) countries
• USA
• Japan
• Republic of Korea

• Brazil
• Australia
• Israel
• Switzerland
• Northern Ireland.

Medical devices: software applications (apps) | 08 July 2021

In UK, standalone software and apps that meet the definition of a medical device are still required to be UKCA marked in line with the Medical Device Regulations 2002 (as amended) (UK MDR 2002) in order to ensure they are regulated and acceptably safe to use and also perform in the way the manufacturer/ developer intends them to. The document covers information on classification, suggestions on how to address the main aspects of the UKCA marking process and responsibilities for reporting and correcting when things go wrong.

Importing investigational medicinal products into Great Britain from approved countries | 07 July 2021

Sponsors of UK clinical trials that import investigational medicinal products (IMPs) into Great Britain from outside the UK will need to review their existing supply chains. The purpose of this guidance is to describe the principles for the management and oversight of the import of IMPs to Great Britain from listed countries. There is a one-year transition period from 1 January 2021.

The following devices must be registered with the MHRA from 1 September 2021:
• Class IIa medical devices
• Class IIb non-implantable medical devices
• IVD List B products
• Self-test IVDs

US FDA

Medical Device Development Tools (MDDT) | 24 August 2021

The FDA’s Medical Device Development Tools (MDDT) program is intended to facilitate device development and timely evaluation of medical devices, and promote innovation, by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making.

510(k) Third Party Performance Metrics and Accreditation Status | 18 August 2021

The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA) to improve the efficiency and timeliness of the FDA’s 510(k) process. Under the program, the FDA accredits third parties (or accredited persons, now known as third party review organizations) that are authorized to conduct the primary review of 510(k)s for eligible devices. Under MDUFA IV, the FDA committed to publishing the performance of individual accredited Third Parties with at least five completed submissions on this page (for example, rate of not substantially equivalent (NSE), average number of holds, average time to substantially equivalent (SE)).

Medical Device User Free Rates for Fiscal Year 2022 | 06 August 2021

USER FEES FOR FY2021 – Annual Establishment Registration Fee : $5,546

USER FEES FOR FY2021 – Annual Establishment Registration Fee : $5,672

All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

Accreditation Scheme for Conformity Assessment | 05 August 2021

The ASCA Pilot is an accreditation scheme that capitalizes upon the increasingly prominent role that standards play in regulatory science and practice. The voluntary ASCA Pilot is intended to enhance product reviewers’ and device manufacturers’ confidence in medical device testing, which should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes ASCA Pilot testing. Ultimately, the ASCA Pilot is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.

Federal Register: Guidance : Remanufacturing of Medical Devices | 05 August 2021

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of June 24, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled “Remanufacturing of Medical Devices.” The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Federal Register: Guidance : Agency Information Collection Activities; Proposals Submissions, and Approvals: Medical Device Recall Authority | 05 August 2021

The Food and Drug Administration (FDA, the Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

HEALTH CANADA

Classification of products under the Food and Drugs Act (F&DA) | 22 July 2021

The Food and Drugs Act (F&DA) and its regulations serve as a basis for the classification of drugs, devices, food, and cosmetics. and its regulations serve as a basis for the classification of drugs, devices, food, and cosmetics.




Classification of products under the Food and Drugs Act (F&DA)

Definitions outlined in section 2 of the F&DA are the foundation of classification for drugs, devices, food, and cosmetics. The criteria used for classification vary depending on the interface or product type. Four important criteria for classification include:


• Representation (e.g., any written claims, pictures, symbols, indications, conditions of use, etc.)
• Product purpose and intended use (i.e., the role of the product in fulfilling its claimed effect)
• Composition (i.e., the ingredients, components, structure of the product, and their contribution to
the claimed effect)
• Format (e.g., products in conventional food formats such as prepackaged, ready-to-consume
beverage products, bars, cereals, etc. versus dosage formats such as tablets or capsules)

Classification of products at the drug-medical device interface | 22 July 2021

The present revision is intended to reflect the recently implemented Ministerial Schedule, enacted through the Budget Implementation Act (BIA) in 2019. The new authorities allow the Minister to determine a single set of regulations that would apply to a health product that simultaneously meets more than one of the definitions outlined in the Food and Drugs Act (F&DA). The new Schedule is intended to improve consistency, predictability, and transparency of classification decisions for industry stakeholders.

COVID-19 rapid antigen testing devices that use serial testing for individuals without symptoms: Notice to industry| 09 July 2021

Rapid antigen tests are easy to use and provide results in 15 minutes on average. However, their sensitivity is lower than that of molecular RT-PCR tests. Tests with sensitivity below 80% will not be authorized. This position aligns with the minimum value required by other regulatory agencies (for example, U.S. FDA, WHO, U.K. MHRA, Germany’s PEI). As such, Health Canada is introducing more flexibility during the review process of antigen tests that use serial testing for individuals without symptoms. The purpose of this notice is to communicate to industry this new policy and submission requirements.

AUSTRALIA TGA

Australian regulatory guidelines for sunscreens (ARGS) | 28 July 2021

The Therapeutic Goods Administration (TGA) is embar

The Australian Regulatory Guidelines for Sunscreens (ARGS; the Guidelines) describe the regulatory requirements and standards for sunscreens (and their ingredients) regulated as therapeutic goods in Australia by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 as at the date of publication. To these Guidelines, sunscreens that are regulated as therapeutic goods under the Act are referred to as ‘therapeutic sunscreens’. Unless excluded, therapeutic sunscreens include:

• Primary sunscreens: Products that are used primarily for protection from UV radiation.
• Some secondary sunscreens: Products with a primary purpose other than sun protection, but which also contain sun screening agents.
Many secondary sunscreen products, such as cosmetic sunscreens, are not considered to be therapeutic goods and are ‘excluded’ from therapeutic goods legislation.

Is my software regulated? | 27 July 2021

Recent reforms have been implemented to clarify the requirements of regulated software based medical devices, including introducing several exclusions and exemptions for specific types of software products:
• Excluded products are not medical devices and are not subject to any TGA regulatory requirements.
• Exempt software is a medical device but is not subject to all regulatory requirements. Upcoming guidance on Clinical Decision Support Software will provide detailed guidance on the exemption, including which products are covered, and which requirements still apply.

The purpose of the document is to guide developers and users of software to decide which software and apps are medical devices (as defined by Therapeutic Goods Regulations) and which are general health management and fitness software.

Consultation: Proposed refinements to the regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin | 19 July 2021

In December 2019, an amendment to the regulations for medical devices introduced new classification rules for medical devices that are substances intended to go into the human body through an orifice or be applied to the skin and are absorbed or dispersed. The new rules take effect on 25 November 2021. This amendment followed a public consultation process conducted by the Therapeutic Goods Administration (TGA) in early 2019.

Medical devices and IVDs: Suspensions from the ARTG | 09 July 2021

Following a review by the TGA, medical devices (including IVDs) can be suspended from the Australian Register of Therapeutic Goods. These suspensions are made by the Secretary under section 41GA of the Therapeutic Goods Act 1989(link is external). Medical devices and IVDs can also be suspended from the ARTG if the conformity assessment certificate applying to that kind of device is suspended under section 41GF.

Medical devices reforms: Enhancements to post-market monitoring | 05 July 2021

The TGA reporting forms system was updated in 2019 to improve monitoring and tracking of device incident reports, following feedback from stakeholders. A report can be now lodged electronically, and previously reported incidents, initial reports and follow-up reports can be updated with additional information. The status of reports can be reviewed, and past reports can be viewed. This project has been established to enhance the adverse event reporting processes.

SINGAPORE HSA

Consultation on Regulatory Guidelines for Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS) | 19 July 2021

The Medical Devices Branch (MDB) has released a draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) for stakeholders’ consultation. This document draws reference from the international Medical Device Regulators Forum (IMDRF)’s guidance on Software as a Medical Device (SaMD) to provide an internationally harmonised approach to determining the risk classification of a Standalone Medical Mobile Application (SaMD).

RUSSIA

Resolution of the Government of the Russian Federation of June 30, 2004, No. 323 | 21 July 2021

The Government of the Russian Federation decides to approve the enclosed Regulations on the Federal service on supervision in the field of health care as amended by the Decree of the Government of the Russian Federation of 19.06.2012 N 614. The Federal Service for Supervision in The Field of Healthcare
(Roszdravnadzor) is a federal executive body that performs the functions of control and supervision in the field of healthcare. The Federal Service for Supervision in the Field of Healthcare shall exercise the following powers:


• state control over the circulation of medical devices
• conducting inspections of compliance by subjects of circulation of medical devices
• issuance of permits for the import into the territory of the Russian Federation of medical devices for the purpose of their state registration
• conducting control purchases to verify compliance with the ban on the sale of falsified medical devices, substandard medical devices, and counterfeit medical devices
• monitoring the safety of medical devices, registration of side effects, adverse reactions when using medical devices, facts and circumstances that create a threat of harm to life and health of people when handling registered medical devices.
• issue permission to import medical devices into the Russian Federation for the purpose of their state registration
• carries out and maintain state registration of medical devices
• receives and records notifications on the beginning of activities in the field of circulation of medical devices (except for clinical trials of medical devices, their production, installation, adjustment, application, operation, including maintenance, as well as repair)
• carries out the organization of inspection of the production of medical devices and evaluation of the quality management system
• issue permits for clinical trials (studies) of medical devices

Typical mistakes when submitting documents for obtaining permits for the import of medical devices for the purpose of their state registration | 21 June 2021

A list of common mistakes and proper information to produce in the documents.

SWITZERLAND SWISSMEDIC

KPTPO: Updating of annexes 5, 6 and 8–10 | 01 July 2021

At a meeting of Swissmedic’s Agency Council on 7 May 2021 following the conclusion of the consultative
process involving subject-matter experts and official bodies, it was decided that Annexes 5, 6 and 8–10 of
the KPTPO should be amended with effect from 1 July 2021.
The following KPTPO annexes have been revised:
• Annex 5: List of lozenges
• Annex 6: HAS list
• Annex 8: Gemmotherapy list
• Annex 9: List of standard works
• Annex 10: TAS list

Updated Guidance for Swiss Distributors and Importers | 16 July 2021

The MedDO has undergone a final revision and measures have been implemented to dampen the previous negative effects, guaranteeing adequate market surveillance of medical devices in Switzerland. If the MRA does not update soon, the measures will serve as a temporary solution until Switzerland has established its own medical device regulation independent of European law and infrastructure. This would involve another revision of the relevant legislation, including the MedDO.

June Newsletter

EU Regulations

European Medical Device Nomenclature (EMDN) – Questions and Answers | 15 June 2021

The European Commission (MDCG) published a question and answers article for European Medical Device Nomenclature (EMDN). European Medical Device Nomenclature (EMDN) supports the functioning of the European database (EUDAMED). EMDN will be used for the registration of medical devices in EUDAMED by manufacturers. It explains the term EMDN, how EMDN is created, its key principles, the structure of EMDN.

MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives, and importers subject to the obligations of Article 31 MDR and Article 28 IVDR | 23 June 2021

The document aimed at addressing questions relating to the registration in EUDAMED of actors other than manufacturers, authorized representatives, and importers subject to the obligations of Article 31 of Regulation (EU) 2017/745 on medical devices (MDR) and/or Article 28 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It also clarifies the cases where an Actor ID is issued instead of an SRN.

Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | 7 June 2021

European commission has issued a plan for implementation of in vitro diagnostic medical devices regulation (EU) 2017/746. This plan serves as a living document to monitor their implementation. The status and timelines of the items will be updated to reflect the progress of the work.

UK MHRA 

Operation Pangea: Officers from the Medicines and Healthcare products Regulatory Agency (MHRA) have seized millions of illegally traded medicines and medical devices | 8 June 2021

In a week of action coordinated by Interpol, this year’s ‘Operation Pangea’ ran from 18 to 25 May and saw over 100 countries joining forces to seize non-compliant medical products and to identify and remove thousands of illegally operating websites and URLs offering medicines and devices. The operation also involved coordinating the arrests of several suspected organized criminals. The MHRA will be following the week of action with a detailed analysis of the global results to create a better understanding of current and emerging threats. This work includes the identification of ‘hotspot’ exporting countries, favoured high-risk medicines being traded on the black market, and the ever-evolving business models of criminals worldwide seeking to take advantage of the public.

US FDA

Clinical Outcome Assessments (COAs) in Medical Device Decision Making | 21 June 2021

A clinical outcome assessment (COA) describes or reflects how a person feels, functions, or survives and can be reported by a health care provider or a non-clinical observer, through performance of an activity or task or by the patient. For regulatory purposes, high-quality information from COAs can provide valuable evidence for benefit-risk assessments and can be used in medical device labeling to communicate the effect of a treatment on patient symptoms and functioning. COAs may also be used to help measure the safety of the device and measure how well the device performs in treating or diagnosing the condition.

HEALTH CANADA

Off-label advertising and sale of rapid antigen tests under workplace screening program: Interim Enforcement approach | 15 June 2021

There are currently various technologies to detect SARS CoV-2, the virus that causes COVID-19. While some rapid antigen detection tests (RADTs) have been approved for people without symptoms,

most RADTs are indicated for use on people with symptoms and are to be conducted by laboratory personnel, healthcare professionals or trained operators. Health Canada has authorized several RADTs under two interim orders:

  1. 1. interim order No. 1 for importing and selling medical devices (March 18, 2020, to March 1, 2021)
  2. 2. interim order No. 2 for importing and selling medical devices (enacted March 1, 2021)

The interim enforcement discretion will be in effect until December 31, 2021. The exception is if :

  1. 1. Post-market monitoring identifies new risks or
  2. 2. There is no longer a need to apply this discretion based on public health status.

AUSTRALIA TGA

Custom made medical devices | 30 June 2021

On 25 February 2021, a new framework for regulating personalized medical devices commenced. The framework includes a new definition for custom-made medical devices. The impact of the new definition is most devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG).

Medical device reforms: Conformity Assessment Bodies | 30 June 2021

Conformity assessment is the systematic and ongoing examination of evidence and the application of procedures to ensure a medical device complies with the essential principles for medical devices. Evidence that a device has undergone an appropriate conformity assessment procedure must be held by the manufacturer before a device can be included in the Australian Register of Therapeutic Goods (ARTG). Previously, Australian medical device manufacturers could only apply for a conformity assessment certificate from either the TGA or an overseas Notified Body. To provide additional flexibility and timeliness, the Australian Government agreed to regulatory changes that allow other Australian corporations that demonstrate appropriate experience and competence to undertake conformity assessment of medical devices. An Australian CAB must demonstrate they can perform product assessments and quality management system audits under the Australian conformity assessment body framework. The TGA remains responsible for including medical devices in the Australian Register of Therapeutic Goods (ARTG).

Regulatory changes for custom-made medical devices | 21 June 2021

On 25 February 2021, a new regulatory framework commenced changing the way the Therapeutic Goods Administration (TGA) regulates medical devices that are designed, manufactured, assembled, or adapted to meet the needs of an individual. The changes are collectively referred to as the personalized medical devices framework (the Framework). The Framework introduced the following:

On 25 February 2021, a new regulatory framework commenced changing the way the Therapeutic Goods
Administration (TGA) regulates medical devices that are designed, manufactured, assembled, or adapted
to meet the needs of an individual. The changes are collectively referred to as the personalized medical
devices framework (the Framework). The Framework introduced the following:

  1. New definitions for types of personalized medical devices, greatly reducing the number of devices
    that can be supplied under the custom-made medical device exemption.
  2. New conditions of exemption for custom-made medical devices, in the form of requirements to:
    • submit an annual report detailing all custom-made medical devices supplied in the previous
    financial year.
    • Allow the TGA to inspect production facilities.
    • retain documentation about custom-made medical devices for 5 years (for Non implantable devices)
    or 15 years (for implantable devices).
    • Provide information about each custom-made medical device to the intended recipient.
  3. The new concept of a Medical Device Production System (MDPS) which, once fully implemented,
    will provide options to healthcare providers wishing to produce personalized devices for treating
    their patients and updates to the classification rule for medical devices that record diagnostic images
    to include a broader range of technology now used for the purposes of recording patient anatomy for
    diagnosis and investigation, including anatomical models.

SINGAPORE HSA 

Mean applicant screening response time | 23 June 2021

HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the new and major variation applications accepted within the period of 01 Oct 2020 to 31 Mar 2021, the mean screening time taken by HSA was 31.9 Working Days (WD) for New Drug Application (NDA), 33.6 WD for Generic Drug Application (GDA) and 19.2 WD for Major Application Variation (MAV) applications, respectively.

Below are bi-annual updates of the mean applicant response time for the new and major variation applications:

Mean Applicant Response Time
Period NDAGDAMAV
01 Oct 2020 to 31 Mar 2021Number of applications6210979
Mean Applicant Response Time (WD)33.240.217.0

PAKISTAN DRAP

Notification regarding amendments in form-2 of the Medical Devices Rules,2017 | 7 June 2021

The Drug Regulatory Authority of Pakistan (DRAP) on recommendation of the Medical Devices Board, made the following amendments in Form-2 sub-rule (3) of rule 63 of the Medical Devices Rules, 2017: The entries in column (2) at sub-serial number (iv) and (viii) of serial number 2 shall be omitted and remaining entries shall be renumbered accordingly.

SWITZERLAND SWISSMEDIC

Information from Swissmedic about MedDO | 19 June 2021

If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorized representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU. The transitional periods defined in Art. 104a MedDO apply to the authorized representative.

July Newsletter

EU Authorised Representative

EU Authorised Representative

EU MDR

EU MDR - omcmedical.com

Responsibilities of EU Authorised Representative

• When a device manufacturer is established outside of the European Union, the manufacturer needs to appoint an authorised representative to place the medical device in one of the member states. An Authorized Representative is any person naturally or legally established in the European Community who can act on behalf of the manufacturer.

• A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory. The authorised representative must provide a copy of the mandate to the competent authority when requested.

Role of EU Authorised Representative

  • Verify that the EU declaration of conformity and technical documentation has been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
  • Keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of competent authorities for the period.
  • Comply with the registration obligations and verify that the manufacturer has complied with the registration obligations.
  • In response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned.
  • Forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.
  • Cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
  • Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
  • Terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

Registration in EUDAMED

1. Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

2. The system is a collection of databases and electronic systems. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable.

3. Register here: https://webgate.ec.europa.eu/eudamed/landing-page#/

4. EUDAMED is structured around six interconnected electronic systems and a public website:

a) Actors registration (Economic Operators)
b) UDI/Devices registration
c) Notified Bodies and Certificates
d) Clinical Investigations and performance studies
e) Vigilance and post-market surveillance
f) Market Surveillance

Purpose of EUDAMED

  • To enable the public to be adequately informed about devices placed on the market, the corresponding certificates are issued by notified bodies and the relevant economic operators.
  • To enable unique identification of devices within the internal market and to facilitate their traceability.
  • To enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under articles 62 to 80, article 82, and any acts adopted pursuant to Article 81.
  • To enable manufacturers to comply with the information obligations laid down in articles 87 to 90 or in any acts adopted pursuant to Article 91.
  • To enable the competent authorities of the member states and the commission to carry out their tasks relating to this regulation on a well-informed basis and to enhance the cooperation between them.

Information in EUDAMED

  • Depending on the applicable directive, Eudamed2 contains data

a) On registration of manufacturers, authorised representatives, and devices
b) Declaration of conformity
c) Justification of the classification according to Annex IX
d) A copy of the ISO certificate/Proof of QMS
e) Relating to certificates issued, modified, supplemented, suspended, withdrawn, or refused
f) Obtained in accordance with the Medical Device Vigilance System
g) Information on clinical investigations

Timeline for registration of EU Authorised Representative

  • “With regard to timelines for device registration, the text of the MDR presents an inconsistency. On the one hand, Article 123(3)(d) lists the full Article 29 as being applicable from the application dates or, if EUDAMED is not functional on time, six months after the date of publication of the notice referred to in Article 34(3). On the other hand, Article 123(3)(e) grants an additional 18-month transitional period for obligations contained in Article 29(4).
  • Taking into account:

➢ The declared will of the co-legislator to grant an 18-month additional transitional period for device registration and registration of certificates,
➢ The logical correspondence and complementary character of device data elements in Part A (Section 2) and Part B of Annex VI,
➢ The need to ensure that information on devices in EUDAMED is not displayed to public in a partial or misleading nature.

  • The obligation for registration in EUDAMED of device data elements listed in both part A, Section 2, and Part B of Annex VI, shall be applicable as from the timelines indicated in Article 123(3)(e) (meaning from 18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of publication of the notice referred to in Article 34(3)).

Registration Data Sets – MDR

Registration Data Sets - MDR - omcmedical.com

Registration Data Sets – MDR (system/procedure pack)

Registration Data Sets - MDR (system/procedure pack) - omcmedical.com

How we assist you with this process?

  • EU MDR, IVDR gap analysis
  • EU MDR, IVDR compliance
  • EUDAMED registration
  • Act as your EU Authorised Representative
  • Help to be in compliance with EU local registrations like Portugal, France, Italy, Germany etc.,
  • Document translations in all EU languages.