On 20 March 2023, the MDR and IVDR amending Regulation entered into force. The amendments to the MDR and IVDR therefore now apply throughout the Union which, by way of reminder, includes Norway, Iceland, Liechtenstein and Turkey.

To recap, the key aspects of the Regulation include:

• Extension of the transition periods during which devices with MDD[1] or AIMDD[2] certificates can continue to be placed on the market or put into service to:
• • 31 December 2027, for class III and most class IIb implantable devices; and
  • 31 December 2028, for other class IIb, class IIa and class I sterile and measuring devices.
• Extension of the validity of MDD and AIMDD certificates (and resurrection of certain already expired certificates).
• Extension of the transitional period for ‘up-classified’ devices – devices for which the conformity assessment did not involve a Notified Body under MDD but will under MDR can continue to be placed on the market or put into service until 31 December 2028.
• Removal of the end of the so-called “sell-off” periods under each of the MDR and IVDR – devices lawfully placed on the market under the applicable transitional provisions can continue to be made available indefinitely.
• Introduction of additional conditions for manufacturers to satisfy in order to benefit from the extended transition periods under the MDR.

For further detail, please see our earlier post: “MDR and IVDR transition extension: European Commission publishes amendment Regulation”

Next steps

The European Commission is due to publish guidance on the amending Regulation later this week which is expected to clarify outstanding queries, such as how to demonstrate the validity of extended/resurrected certificates and the definition of a ‘substitute’ device.

The first upcoming deadline under the amended MDR is on 26 May 2024, by which date manufacturers must have implemented an MDR-compliant quality management system and lodged a formal application with a Notified Body for an MDR conformity assessment of their device.

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[1] Medical Devices Directive 93/42/EEC
[2] Active Implantable Medical Devices Directive 90/385/EEC