Europe – Article 59 and European CE Marking for medical devices

On April 23rd, 2020 Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on Medical Devices (MDR) introduced a one year delay in the date of application of the MDR. It also changed Article 59 of the Regulation:

  • Until the MDR applies, the current Medical Device Directives are also brought within the scope of Article 59.
  • While the MDR applies from May 26th, 2021, Article 59 will apply from April 24th, 2020.

Article 59 sets out how authorization of CE Marking requirements derogation for medical devices (not IVDs) can be done. In the light of the COVID-19 pandemic it may be justified to speed up the paperwork for devices that are being placed on the EU market, while at the same time Notified Bodies are struggling to perform audits and reviews while travel restrictions apply.

Article 59 guidance and CE Mark derogation

The European Commission has published guidance on this subject. This guidance specifies the following procedure for the derogation authorization:

  1. At least one Member State authorizes a derogation for CE Marking and notifies the European Commission about that;
  2. The justification for that derogation has been shared in full with the European Commission and the other Member States;
  3. The derogation has also been shared with the European Commission and Member States, as well as any result from surveillance and monitoring activities;
  4. The derogated devices must be clearly identified, because without the CE Mark it is likely the device is not registered in Eudamed or other relevant databases;
  5. All relevant documentation, including any technical documentation, that have been shared with the Member State must be shared with the European Commission and the other Member States…