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.
