MDR Article 59
European lawmakers have developed Regulation (EU) 2020/561 amending Article 59 of the MDR. Article 59 covers Member States exempting devices used on their territory from CE Marking. It has been changed to allow the European Commission to expand the use of devices to other markets once a device has been exempted from CE Marking in one Member State. This will not only allow for fast responses to challenges in a situation like the coronavirus pandemic, but also help in other situations such as the man-made Brexit problem. Although the date of application of the MDR has been moved to 2021, the implementation of Article 59 MDR has been brought forward to April 24, 2020. Therefore it is interesting to see how the European Commission will deal with devices that are exempted from CE Marking in one or more Member States, and how fast this process will proceed. At this moment it appears there are no implementing acts proposed to support this aim.
The UK MHRA’s plan
From that perspective it is interesting to see that the UK Medicines & Healthcare Products Regulatory Agency (MHRA) appears to be preparing for a hard Brexit. MHRA has a well-designed and effective derogation procedure and the results are now publicly available. This list contains over 50 devices or device families and helps UK citizens to verify if a device without CE Marking can be used. In case there are problems with device supplies as a result of Brexit – possibly on top of problems caused by the COVID-19 pandemic – this procedure and its list can help in allowing devices to remain available for British healthcare providers.
Emergo expects other Member States will soon create their own lists, and it is likely the first Article 59 MDR-related implementing act will soon be published.
Related European MDR resources from Emergo by UL:
- EU Medical Devices Regulation preparation and compliance resource center
- Brexit transition consulting for medical device and IVD manufacturers
- Whitepaper: Preparing for a no-deal Brexit
Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL.