Introduction about Medical Device Regulation in Europe
Introducing the Medical Device Regulation in Europe addresses several challenges. It aims to enhance medical device regulation in Europe to ensure a higher level of safety and effectiveness. The need for the MDR arises from various factors, including shortcomings identified in the previous regulatory framework (Medical Device Directives) and the evolving landscape of medical technologies.
Rapid technological advancements in the field of medical devices have led to the development of increasingly complex and innovative products. The MDR adapts the regulatory framework to account for these technological advancements and to ensure the safety and performance of new and emerging devices.
The primary objective of the MDR is to prioritize patient safety. By introducing more stringent requirements for conformity assessment, clinical evidence, and post-market surveillance, the regulation aims to reduce the risk of harm to patients and users of medical devices. The MDR promotes transparency by introducing measures such as the European Database on Medical Devices (EUDAMED).
This database allows better traceability of medical devices in the market and facilitates communication between regulatory authorities, manufacturers, and other stakeholders. The MDR places a greater emphasis on post-market surveillance activities, ensuring that medical devices are continually monitored once they are on the market.
This enables timely identification and response to safety issues and improves overall device performance.
The MDR aims to harmonize the regulatory requirements for medical devices across EU member states. This harmonization facilitates a more consistent and predictable regulatory environment for manufacturers, streamlining the process of bringing products to market.
The MDR introduces a more refined classification system for medical devices, taking into account the potential risks associated with devices. This allows for a more accurate categorization of devices based on their characteristics and intended use. The Medical Device Regulation in Europe clarifies the roles and responsibilities of economic operators, including manufacturers, authorized representatives, importers, and distributors.
This enhances accountability throughout the supply chain, ensuring that each party plays a defined role in ensuring device compliance and safety.
The MDR aligns with global best practices and standards, contributing to international regulatory convergence. This alignment is essential for manufacturers who intend to market their devices globally. The MDR addresses identified gaps and weaknesses in the previous regulatory framework, the Medical Device Directives (MDD).
These gaps included challenges related to the classification of devices, insufficient requirements for clinical evidence, and variations in the interpretation and application of the directives among member states.
Medical Device Compliance
Medical device compliance refers to the adherence of medical devices to regulatory standards and requirements set by relevant authorities. Ensuring compliance is crucial to guarantee the safety, efficacy, and quality of medical devices, protecting both patients and healthcare providers.
The key aspects of medical device compliance are:
Regulatory Authorities
Different countries have regulatory bodies responsible for overseeing medical devices. For example, the U.S. FDA in the US, the European Medicines Agency (EMA) in the EU, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Manufacturers must comply with the regulations specific to the regions where they intend to market their devices.
Classification of Devices
Medical devices are often categorized based on their risk level. The risk classifications include Class I, IIa, IIb, and III in the European Union under the MDR.
Quality Management Systems (QMS)
Compliance often involves the implementation of a QMS, such as ISO 13485. This ensures that manufacturers establish and maintain processes to consistently produce safe and effective medical devices.
Pre-market Approval (PMA) or Conformité Européenne (CE) Marking
Before marketing a medical device, manufacturers may need to obtain regulatory approval or clearance. In the U.S., this may involve the submission of a PMA application, while in the EU, devices need to be CE marked according to applicable regulations.
Post-market Surveillance
Manufacturers are required to monitor and report adverse events and product issues after a device is on the market. This involves maintaining a system for post-market surveillance and reporting to regulatory authorities.
Labelling and Instructions for Use
Compliance includes providing accurate and clear labelling for medical devices. Instructions for use must be easily understandable, and information about potential risks and proper usage should be prominently displayed.
Risk Management
Manufacturers must conduct risk assessments for their devices to identify and mitigate potential risks throughout the product lifecycle.
Clinical Data and Performance
Submission of relevant clinical data is often required for regulatory approval. This data supports claims regarding the safety and performance of the medical device.
Adherence to Standards
Compliance with relevant industry standards, such as those developed by the International Electrotechnical Commission (IEC) or ASTM International, is often necessary to demonstrate that a device meets specific criteria.
Audits and Inspections
Regulatory authorities may conduct audits and inspections to ensure that manufacturers are complying with all applicable regulations.
EU Medical Device Directive
The Medical Devices Directive (93/42/EEC) was one of the main directives governing the marketing and distribution of medical devices within the European Union. It provided the regulatory framework for the safety and performance of medical devices and outlined essential requirements that devices needed to meet.
The MDR (2017/745) came into effect in May 2021, replacing the Medical Devices Directive. It introduced more stringent requirements for the approval and surveillance of medical devices in the European Union.
The MDR emphasizes increased transparency, traceability, and the involvement of notified bodies in the conformity assessment process.
The MDR came into force on May 26, 2017, but the date of application was postponed several times. As of my last update, it was set to be fully applicable from May 26, 2021.
Key Changes and Features of Medical Device Regulation in Europe:
Stricter Scrutiny: The MDR introduces more rigorous pre-market assessment procedures, including enhanced scrutiny of high-risk devices.
Unique Device Identification (UDI): It mandates the use of a UDI system for better traceability of devices throughout their lifecycle.
EUDAMED Database: The establishment of the European Database on Medical Devices (EUDAMED) for the registration and dissemination of information about medical devices.
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF): Strengthened requirements for post-market surveillance and clinical follow-up to monitor and report on device performance.
According to the MDR 2017/745, a ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.
Medical Device Certification in Europe
The CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is mandatory for various product categories, including Medical Device Regulation in Europe.
For medical devices, obtaining the CE marking signifies compliance with the applicable European regulations, such as the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).
The CE marking demonstrates that a product meets the essential requirements outlined in European Union (EU) directives or regulations, ensuring a high level of safety and performance. Medical devices that are intended to be placed on the market within the EEA must bear the CE marking.
This includes a wide range of products, from simple devices to complex technologies. The CE marking allows a medical device to be legally placed on the market and sold within the EEA. Various economic operators in the supply chain, including manufacturers, importers, distributors, and authorized representatives, have specific responsibilities related to the CE marking process.
As part of the new regulatory framework, information about medical devices, including their CE certificates, will be registered in the European Database on Medical Devices (EUDAMED).
Manufacturers must continuously ensure that their devices remain in compliance with regulatory requirements. This includes monitoring post-market surveillance data and promptly addressing any safety concerns.
Manufacturers of Medical Device Regulation in Europe must follow a series of steps to affix the CE marking:
Conformity Assessment: The manufacturer assesses the device’s conformity with applicable EU regulations. This assessment can involve self-certification or the involvement of a Notified Body, depending on the device’s risk classification.
Technical Documentation: The manufacturer prepares comprehensive technical documentation that demonstrates compliance with essential requirements, including design, manufacturing, and performance data.
Quality Management System (QMS): Manufacturers must implement and maintain a QMS in accordance with relevant standards, such as ISO 13485.
Declaration of Conformity: Once the conformity assessment is successful, the manufacturer issues a Declaration of Conformity, declaring that the device meets the requirements of applicable EU regulations.
Affixing the CE Mark: The CE marking is affixed to the product, packaging, or accompanying documentation, indicating that the device complies with EU regulations.
Europe healthcare device standards
European healthcare device standards are a set of technical specifications and criteria that provide a common language and framework for the design, manufacturing, and performance of healthcare devices within the European Union (EU).
These standards are developed by various standardization organizations, and compliance with these standards helps manufacturers meet regulatory requirements and ensure the safety and efficacy of their devices.
Some of these standards are:
ISO Standards: cover various aspects, including quality management, risk management, and specific requirements for different types of medical devices.
Electromagnetic Compatibility (EMC) Standards: Healthcare devices, especially electronic and electrical equipment, must comply to ensure that they do not interfere with other devices and are not susceptible to interference. Common standards include EN 60601-1-2 for medical electrical equipment.
Biocompatibility Standards: ensure that materials used in devices do not cause adverse reactions when in contact with the human body. EN ISO 10993 is a series of standards addressing biocompatibility.
Quality Management System (QMS) Standards: Compliance with quality management system standards is essential for medical device manufacturers. ISO 13485 is an international standard, and compliance with it is often required for the CE marking of medical devices in Europe.
Risk Management Standards: Risk management is a critical aspect of medical device design and manufacturing. EN ISO 14971 is the standard that outlines the principles for risk management.
Sterilization Standards: standards like EN ISO 11135 for ethylene oxide sterilization and EN ISO 17665 for moist heat sterilization provide guidelines for ensuring the effectiveness of the sterilization process.
Software Standards: As software plays an increasingly important role in healthcare devices, standards like IEC 62304 provide guidance on the software life cycle processes.
Usability and Human Factors Standards: Standards in this category address the design and usability of healthcare devices to ensure that they are user-friendly and safe. EN ISO 14971 and IEC 62366 are relevant standards.
Labelling Standards: Standards related to labelling provide guidance on the information that should be included on medical device labels. EN 980 and EN ISO 15223-1 are examples.
It’s important for manufacturers and stakeholders in the healthcare industry to stay updated on the latest standards and ensure compliance with relevant regulations, as these standards play a crucial role in demonstrating conformity to essential requirements for medical devices in the European market.
Additionally, the specific standards applicable to a particular device depend on its type, classification, and intended use.
Conclusion
In conclusion, the unveiling of the Medical Device Regulation in Europe represents a significant milestone in the evolution of regulatory standards for Medical Device Regulation in Europe. The comprehensive changes introduced by the MDR are driven by a commitment to advancing patient safety, fostering innovation, and adapting to the rapidly evolving landscape of healthcare technologies.
The MDR addresses critical shortcomings identified in the previous regulatory framework, offering a more robust and transparent system for the approval and surveillance of medical devices.
With a heightened focus on risk management, clinical evidence, and post-market surveillance, the MDR aims to ensure that medical devices entering the European market meet the highest standards of safety and efficacy.
Key elements of the MDR include an enhanced classification system, stricter conformity assessment procedures, and the implementation of a Unique Device Identification (UDI) system. These features contribute to a more sophisticated and nuanced approach to regulatory compliance, tailored to the diverse range of Medical Device Regulation in Europe and their associated risks.
The regulation’s emphasis on transparency is evident in the establishment of the EUDAMED, providing stakeholders with a centralized platform for information sharing and increased traceability. This marks a crucial step towards creating a harmonized regulatory environment across EU member states.
As manufacturers navigate the complexities of compliance, understanding the requirements of the MDR becomes paramount. The alignment of the MDR with global standards fosters a seamless transition for manufacturers looking to market their devices internationally, reinforcing the EU’s commitment to global regulatory convergence.
In essence, the EU MDR sets a new benchmark for the medical device industry, demanding higher standards of quality, safety, and accountability. While the transition may present challenges for manufacturers, the long-term benefits lie in a safer and more innovative landscape that ultimately benefits patients and healthcare systems across Europe.
Staying informed about the intricacies of the MDR and collaborating with regulatory experts will be crucial for industry players aiming to navigate this transformative regulatory landscape successfully.
Legacy Devices are the medical devices covered by a valid Directive certificate under Directive 93/42/EEC or Directive 90/385/EEC and continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR).
Those devices should be registered under EUDAMED without Basic UDI-DI and a UDI-DI within 18 months after the application is placed or 24 months if the EUDAMED is not fully functional before the date of application.
This registration is mandatory for the manufacturer in case of any serious incidents and if any field safety actions have been taken, at least before the final vigilance report is submitted.
As per MDR device requirements, any medical device registered under EUDAMED will require Basic UDI-DI and UDI-DI, which gets reflected on the database design for future reference.
These legacy devices will need two other unique access keys (UI) to replace basic UDI-DI and UDI-DI to register under EUDAMED. Instead of Basic UDI-DI, the legacy devices will be assigned EUDAMED DI, and instead of UDI-DI, the legacy devices will be assigned EUDAMED ID.
Registration of Legacy Devices
As per the flowchart above,
If the manufacturer already has UDI-DI assigned to the legacy device, then the EUDAMED DI will be automatically generated based on UDI-DI in the standard format, placing the character “B-“ in front of UDI-DI
If the manufacturer does not have an assigned UDI-DI for the legacy device, then they will be assigned both EUDAMED DI and EUDAMED ID
The EUDAMED DI can be completely assigned by the EUDAMED or partially taken from the manufacturer using their DI code. But the EUDAMED ID should be completely generated by the EUDAMED.
The EUDAMED DI will start with the character “B”, whereas the EUDAMED ID will start with the character “D” other than the first character EUDAMED DI and the ID will include the SRN number, a number assigned to the manufacturer and check digit.
In addition, the manufacturer should enter their directive certificate identification, such as NB number, revision number, certificate number, and expiry date.
EUDAMED allows the linking of the regulation device with the legacy devices, if the regulation device is exactly the same as the legacy device, they can have the same UDI-DI.
This link may happen automatically by EUDAMED, or the manufacturer can create a link manually by assigning a legacy device identifier, which should happen at the level of UDI-DI.
FAQ
What is the difference between Basic UDI-DI and a UDI-DI?
Basic UDI-DI is a DI assigned to the level of unit use of the device, which is a primary identifier for the device model/family . It is mentioned in the reference CE certificates and the Declaration of Conformity. In contrast, UDI-DI is a unique numeric or alphanumeric code of each device itself , which is used as an access key for the UDI database.
What is EUDAMED?
EUDAMED is a European Database of Medical devices operated by the European Commission to register relevant information on medical devices and to ensure the medical devices’ safety, traceability, and transparency as per MDR 2017/745.
When can a manufacturer register under EUDAMED?
The manufacturer can register their device information/UDI voluntarily in EUDAMED. Moreover, it is mandatory to register legacy and regulatory devices within 24 months after the Commission publishes that the EUDAMED is completely functional.
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 formseAF 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
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 drugsubstance 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.
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. interim order No. 1 for importing and selling medical devices (March 18, 2020, to March 1, 2021)
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. Post-market monitoring identifies new risks or
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:
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.
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.
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
NDA
GDA
MAV
01 Oct 2020 to 31 Mar 2021
Number of applications
62
109
79
Mean Applicant Response Time (WD)
33.2
40.2
17.0
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.
