EU extends grace period for transition to Medical Device Regulation
The European Union, recognising that many medical device manufacturers would be unable to meet the deadline for transition to the requirements of the Medical Device Regulation (MDR), have extended the grace period allowed for compliance with the new law. Prominent among the reasons for the postponement of the deadline is the inadequate number of third-party assessors, known as ‘notified bodies’, designated to certify manufacturer’s compliance with the requirements of the Regulation, which are more demanding than those of the repealed Medical Device Directive.
This setback for EU regulators follows an earlier postponement of the deadline for transition to the MDR’s companion statute, the In Vitro Diagnostic Device Regulation (IVDR).
Legislative amendments implemented in February 2023 extend the grace period for transition to the MDR for devices covered by a certificate or a declaration of conformity with the MDD issued before 26 May 2021, the date from which the MDR applies, and that now require certification under the MDR. The grace period is extended from 26 May 2024 to 31 December 2027 for higher-risk devices and to 31 December 2028 for medium- and low-risk devices. Manufacturers must meet certain conditions to benefit from the extra time allowed.
Both the MDR and IVDR originally specified a ‘sell off’ date by which non-compliant devices that have already been placed on the market, and remain available for purchase, should be withdrawn. The February 2023 amendments remove this requirement.
Zenosis module MD01, An Introduction to the Regulation of Medical Devices, is up to date with the changes brought about by the February 2023 amendments.