At the beginning of this year, the Commission filed with the Council and the European Parliament a proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 on the transitory arrangements for medical devices and in vitro diagnostic medical devices.
The proposed regulation aims to revise the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) in order to reduce the very real and imminent danger of medical device shortage across the UK and the continent.
The new transitional period is intended to be the following dates:
- For higher-risk devices (Class III), the deadline is December 31, 2027.
- For medium- and lower-risk devices (Class IIa and IIb), the deadline is December 31, 2028.
- May 26, 2026 for class III implantable custom-made devices*
There is an expectation that the European Parliament will vote on the text of the Commission proposal without amendments at the first reading between February 13 and 16, 2023.
There is acknowledgement in the EU that despite a steady growth in the number of notified organisations designated under Regulation (EU) 2017/745, the overall capacity of notified bodies is still insufficient to ensure conformity evaluation of the huge number of devices covered by certificates and that many manufacturers, particularly small and medium-sized businesses, are not well equipped to demonstrate compliance.
*Subject to the manufacturer's application for a conformity assessment before May 26, 2024.
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