Regulatory Affairs Updates 06/22

Medical Devices - Guidelines and Regulations Worldwide

Areas

Europe
Great Britan
Taiwan
Australia
USA

Europe

Guidance MDCG 2022-2 on Performance Evaluation of IVDs

Under Regulation (EU) 2017/746, performance evaluation (similar to clinical evaluation under the MDR ) is gaining importance. The requirements can be found in Articles 5 and 56 of the IVDR, among others. Until now, there has been little solid to rely on for manufacturers who are now faced with a colossal task. With the Guidance MDCG 2022-2, there is now help in implementing a suitable process and tips for creating a performance evaluation report.

The 31 pages of the Guidance do not answer all questions, but certainly the most. By the way, there are currently 6 IVDR-certified Notified Bodies - just a few weeks before the regulation starts to apply. The extension of the transitional periods is therefore urgently needed to meet the demand. Manufacturers now have until up to May 2027 to prepare an IVDR-compliant performance evaluation.

The guidance is linked here:

Guidance MDCG 2022-2

International News

Great Britain

Amendments on Medical Device Regulations 2002

Since the first of January, new regulations have been in place for medical device manufacturers in the UK. Due to Brexit, Regulation (EU) 2017/745 and Regulation (EU) 20174/746 (charmingly called EU MDR and EU IVDR in the UK) do not apply in England, Scotland, Wales and Northern Ireland. Instead, further amendments are being added to the existing Medical Device Regulations 2002 (UK MDR).

As of this year, UKCA marking is available and will completely replace the European CE mark after June 2023 following a transition period. In addition, manufacturers outside the UK must now register all products with the MHRA through a responsible person. Whether the proponents of the Brexit were aware that it would be so complicated? Probably not. Manufacturers from the UK and the EU can find detailed information on registration in the respective economic areas here:

Guidance Document

Taiwan

Introduction of TCP III

The Technical Cooperation Programme (TCP) facilitates the certification of the quality management system in Taiwan and vice versa for European medical device manufacturers. Basically, the program ensures the exchange of audit reports between European notified bodies and Taiwanese authorities.

With the simultaneous entry into force of the MDR and the Medical Device Act last May, TCP II became invalid and was replaced with TCP III. The six-month transition period is now over and TCP III has been in full force since January. Caution: Your Notified Body must be a member of the agreement!

TCP

Australia

Consultation on TGA Fees and Charges

The fiscal year of the Australian TGA begins in July. Currently, the fees for the coming fiscal year 2022/2023 are being discussed and anyone who wishes to do so can also contribute their opinion in an official consultation process.

In the document open for comment, all cost-driving factors are listed and some interesting info is provided: for example, a study was done last year by PwC, which concluded that the TGA should introduce a time tracking system in the future. Furthermore, the topics 'medical cannabis' and 'nicotine vaping' are currently quite hot topics for the authority.

Those who want to participate in the consultation process still have until 07th of March. The whole process runs as usual via the Consultation Hub.

TGA

USA

Consultation on Section 506J of FD&C Act

The FDA has also launched a consultation, which will run until April. This deals with guidance on the relatively new Section 506J of the FD&C Act. This section states that manufacturers of critical medical devices must notify the FDA of a permanent discontinuance or interruption of manufacturing of those devices during a public health emergency.

In fact, there is an identical guidance in place for the current Covid 19 pandemic as well, but it is to be withdrawn after the pandemic (whenever that may be). The new guidance for general emergencies is intended to fill the gap thereupon and provide guidance on Section 506J compliance. The document can be found here:

FDA Guidance Document