IMPORTANT DATES ARE APPROACHING FOR THE REGULATION OF MEDICAL DEVICES

Companies manufacturing and distributing medical devices need to take into account the following upcoming deadlines to comply with the requirements of Regulation (EU) 2017/745 on medical devices (hereinafter "MDR").

26 May 2024 - By this deadline manufacturers must:

i. ensure the establishment of a quality management system (QMS) in compliance and in accordance with Article 10(9) of the MDR; and

ii. submit an official request to the notified body in accordance with Annex VII, point 4.3, first subparagraph, of the MDR, including at least the MIR (manufacturer incident report) documentation and a list of devices intended to be continuously marketed as “legacy” devices.

26 September 2024 - By this deadline manufacturers shall enter into a written agreement with the notified body in accordance with the second subparagraph of point 4.3 of Annex VII to the MDR.

The notified body will issue a "Confirmation Letter" confirming that the manufacturer and the reported devices meet the requirements of the MDR and can stay on the market during the extended transitional period.

Manufacturers of medical devices must meet these deadlines to ensure compliance with the MDR requirements.

Please contact us if you have any questions about the deadlines and the related obligations.