The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates.
The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation (“EU MDR”). The proposal recognises the challenges in capacity across notified bodies.
Key changes include:
Extend the transitional period for higher-risk devices (class III and certain class IIb implantables) such as pacemakers to comply with EU MDR requirements until 31 December 2027, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with notified bodies).
Extend the transitional period for medium and lower-risk devices (other class IIb devices, class IIa, class Im, Is and Ir devices) such as syringes to comply with EU MDR requirements until 31 December 2028, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with notified bodies).
Extend the validity of certificates issued by notified bodies under Directive 90/385/EEC and 93/42/EEC that were valid on 26 May 2021. Subject to meeting specific conditions, this extension also applies to those certificates that expired before the amendments took effect.
Source MHRA
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