Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to devices, in implementing a recent court decision.
Author: Suzanne Broussard, PhD | February 25, 2022
The European Union (EU) saw 2021 bring important milestones and changes to the implementation of Medical Device Regulation (MDR) 2017/745. Key highlights included compliance dates, expert opinion panels, newly published guidance and standards.
The original deadline of 26 May 2021 for MDR 2017/745 compliance has come and gone, and many medical device manufacturers with devices granted a CE mark under MDD are taking advantage of the 26 May 2024 grace period to become fully complaint with MDR. As of September 2021, the EU notified bodies had granted only 502 conformity assessment certificates, thus, it is anticipated there will be an extreme bottleneck in 2023 and especially in 2024 due to limited notified body availability as manufacturers scramble to meet the May 2024 deadline.
The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.
TEAM-NB, the EU notified body association, warns of disruption in device supply if critical action is not taken to ease the path to implementation. It says the many new medtech regulatory shifts, guidance documents and structures adopted in 2021 must be augmented.
Swiss domestic medtech manufacturers reluctantly accept Switzerland’s new status as a third country to the EU, but the Swiss industry is anxious that new national regulations do not impose higher hurdles than the EU MDR. At present, there is a risk of that happening.
Swiss medtech manufacturers appear to have taken a pragmatic view of the country’s newfound status as a third country to the EU, in the months since the EU Medical Device Regulation took effect. In the absence of the mutual recognition agreement (MRA) with the EU, the MDR does not apply directly in Switzerland, as the medical device directives did, so Switzerland enacted its own national Medical Device Ordinance (MedDO/MepV).
The revised Swiss medical device legislation was put in place to maintain Switzerland’s orientation towards both the MDR and the future IVD Regulation, regarding product quality, safety and efficacy. At some point in the future, a Swiss referendum might lead to a situation where mutual recognition and free market access are once again in place for both parties.
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