European Update: Is an EU MDR Article 59 Derogation a Way to Continue to Market?

By Annette Van Raamsdonk and Evangeline Loh

Yes, possibly. It needs to be in the “interest of public health or patient safety or health.” The member state is authorized based on a “duly justified request” to place on the market a specific medical device that is not compliant with the MDR (“derogation from Article 52”). It is granted for a limited period of time by a member state to either a single patient or a specified larger group. If the derogation is not limited to a single patient, the member state must inform the European Commission (Article 59(2)).

The Commission published in 2020, Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 (2020/C 171/01). While this is intended to be a playbook for EU-wide Article 59 derogations, the guidelines also delineate expectations by member states as well (3. General requirements A. procedural requirements and B. due justification). Of course, it is expected that there be no evidence that the device is/would be “harmful.” In addition, as the derogation is on a member-state basis, support of the paucity of  “suitable substitutes available” is necessary. And, it can be beneficial to have a statement from a health institution as to why the medical device cannot be substituted. Some member states even require such a statement, prior to granting derogation.

In the 2020 MDCG guidance (MDCG 2020-9) on ventilators and related accessories, there was a comment that Article 59 may “ensure short-term supply.” Last year, the MDCG guidance MDCG 2022-11 opined on the use of Article 59. A reminder: it is not intended to be the panacea to the prolonged MDR review timelines, notified body capacity, and manufacturer’s incomplete submissions. There are specific requirements to proceed with Article 59 in the interest of public health or patient safety or health.

And, in our regulatory update on Article 97(1), we stated that an Article 97(1) application and decision would be different from an Article 59 application and derogation. Consistent with MDCG 2022-18 and the concluding section remarks about the difference between the two articles. Hence, an Article 59 derogation from a member state, is really intended to support the supply of critical medical devices on the territory of an EU country, or for example to derogate exceptional use of a device for a specific patient group not covered by the EC certificate. Now what about Article 97?

Stay tuned to our next regulatory update on the application of Article 97.