European Regulatory Roundup, December 2021: Year Ends On High Note For EU IVDR
Executive Summary
There may be a collective sigh of relief over the new deadlines for IVDs under the IVD Regulation, and further progress towards implementation of the MDR and IVDR. But the UK and Swiss medtech regulatory situations are currently causing concern.
As 2021 drew to a close, all eyes were on the IVD Regulation amending proposal, which was due to introduce new transition provisions for the majority of the IVDs.
It was a mainly a question of when this document would be adopted, rather than if, once the Council of the EU decided not to alter the commission’s proposal as long as the European Parliament, too, followed the European Commission’s lead.
And the industry indeed received a festive gift in terms of adoption by the council on 21 December. This was a huge relief for the sector.
It means that the notified bodies, which will be assessing most of these IVDs for the first time and had anticipated an unmanageable demand for their services had the 26 May 2022 IVDR deadline persisted for all products, will now be able to stagger their work in a more manageable way. It also means less pressure for IVD companies, the vast majority of whom have never used a notified before and many of whom are struggling to understand the new detailed and complex requirements of the regulation.
For its part, industry association MedTech Europe called for more guidance and a swift implementation of the IVDR infrastructure.
European Commissioner for Health and Food Safety, Stella Kyriakides, meanwhile, called in early December for EU member states to “equip your authorities with the resources they need” to deal with the 11 pending applications for notified body designation under the IVD Regulation.
In its reaction to the IVDR amending regulation adoption, MedTech Europe pointed out that half of all IVD manufacturers do not yet have a notified body.
December Guidance Documents
The MDCG continued with its mission to publish guidance documents in December, providing clarification on Where And How eIFU Rules Will Apply Under The MDR. The latest document replaces the earlier rules which had been adopted under the medical device directives and which are repealed by this new text. However, the previous rules, (EU) No 207/2012, still apply to devices that are making use of the MDR grace period until 26 May 2024.
Another much-needed guidance document was also published in December, concerning the role of importers and distributors under the MDR and IVDR. Published in a Q&A format, MDCG 2021-27 explains similarities and differences between importer and distributor roles, as well as the position regarding legacy products,
Eudamed
Additionally, the European Commission published an Implementing Regulation explaining some of the fundamental practices that need to be carried out by different actors for Eudamed to operated successfully. This details the processes that actors must go through to obtain access to the European medical device database, explains that authorized users should use the free-of-charge European Medical Device Nomenclature (EMDN) codes when accessing the database, and details what help and training will be available. In addition, it covers what happens if fraudulent activity, malfunctions, or security risks are identified.
EN ISO 14971
There was also good news on progress on the medical device risk management standard, EN ISO 14971. December 28 was the deadline for the public enquiry on two documents that will link the international medical device risk management standard, EN ISO 14971, with the MDR and IVDR.
The new documents, known as Annex ZA (MDR) and Annex ZB (IVDR), will show the link between individual general safety and performance requirements (GSPR) that feature in the new regulations and the relevant clauses in the standard. By complying with the clauses in the standard, manufacturers can argue that they demonstrate compliance with the associated GSPR in the regulations.
UK And Switzerland
Turning to the two countries that have recently cut ties with the EU, the UK and Switzerland, steps are being taken to shape their new medtech regulatory futures.
The UK’s Medicines and Healthcare products Regulatory Agency, the MHRA, is assessing the views of stakeholders in responses to the 465 questions contained in its regulatory consultation, with publication by the MHRA of a consultation response and finalized policy position expected by March 2022. The relevant statutory instruments should be laid by the end of June, and publication of key guidance by the end of December. That leaves just a tight six months until the mid-2023 new UKCA marking deadline.
In Switzerland, meanwhile, industry remains embroiled in discussions with the federal office of public health (FoPH) arguing Switzerland’s new MePV, the local version of the EU MDR, is creating uncertainty and challenging additional new requirements, especially because of Switzerland’s failure to update the mutual recognition agreement with the EU. The new Swiss requirements to relabel medical devices that were approved under the medical device directives.
November
Separately, for November’s roundup, see: European Regulatory Roundup, November 2021: Eudamed Dominates News
Top 10 EU Regulatory Pieces
The most popular EU regulatory articles in December 2021 were as follows: