Nov 27, 2019

European regulators have proposed extending Medical Devices Regulation (MDR) compliance deadlines for devices previously considered Class I by four years, to May 2024.

The European Union has published a second batch of draft corrections (the second corrigendum) to the text of the MDR; the most significant of these corrections targets Article 120(3) of the Regulation addressing devices that were considered Class I under the Medical Devices Directive), but will have to partner with Notified Bodies to undergo conformity assessment for CE Marking under the MDR, resulting in upclassification of these products under the MDR.

Provided that these devices’ declarations of conformity will have been issued before May 26, 2020, the second corrigendum states that these products may remain on the EU market until May 26, 2024.

“Device manufacturers should be aware that the corrigendum is open for comments from Member States for a short time and then the European Parliament will have its turn,” says Ronald Boumans, Senior Consultant, Regulatory Affairs at Emergo by UL in The Hague. “So this change should not be considered final. But for upclassified Class I devices, this is a first sign of good news.”

Learn more about European MDR compliance and timelines at Emergo by UL: