Regulation (EU) 2023/607 - Extension of the transitional period MDR (EU) 2017/745

Szymon Kurdyn

Head of Notified Body
Apr 17 , 2023

With the publication of Regulation (EU) 2023/607 in the Official Journal of the European Union, a long-awaited extension of the MDR (EU) 2017/745 transition period came into effect. As of May 20, 2023, manufacturers of MDD existing devices (known as "legacy devices" according to MDR Article 120) can benefit from longer periods for the certification of their devices as well as further changes:

  1. Extension of MDR transition period until December 31st 2027 for class III and class IIb implantable legacy devices.
  2. Extension of MDR transition period until or December 31st 2028 for other class IIb, class IIa and class Im and Is legacy devices, as well as devices qualified as class I under the directives but which conformity assessment procedure under the MDR requires the intervention of a Notified Body.
  3. Introduction of a transition period until May 26th 2026 for class III custom-made implantable devices.
  4. Removal of the "sell-off" period in the MDR (Article 120(4)). 

However, the extension is subject to several conditions to ensure that only safe devices may benefit from the new transition period. Therefore, manufacturers must:

  1. By May 26th 2024, establish a quality management system (QMS) compliant with MDR; and
  2. By May 26th 2024, submit a formal application for the conformity assessment under MDR; and
  3. By September 26th 2024, have an mutually signed written agreement with the Notified Body for the conformity assessment under MDR.

In addition, the extension of the transitional regime only applies to MDR legacy devices that:

  • Continue to comply with directive 93/42/EEC; and
  • Do not present significant changes in design or intended use; and
  • Do not present unacceptable risks to the health and safety of patients and users.

The new regulation also provides an additional requirement for legacy devices with an expired certificate. These products may only benefit from the extended transition period insofar as:

  • The manufacturer – before the MDD's certificate's expiration – has concluded a contract with a Notified Body for conformity assessment under the MDR; or alternatively
  • The manufacturer benefitted from an exemption under either Article 97 or 59 of MDR, which provide derogations from applicable rules in particular cases

The extension of the transition period meets the demands of the medical device industry, which has long been calling for a more flexible deadline to certify MDR legacy devices and is undoubtedly good news for medical device manufacturers. However, the need to meet the first deadline May 26th 2024 requires prompt action to ensure compliance with the new rules.

If you are interested or have any questions about this procedure, you can contact us here.

Your Notified Body DQS MED

Author
Szymon Kurdyn
Head of Notified Body

Product Manager ISO 13485

Szymon.Kurdyn@dqs-med.de

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