Extension of the deadline for the transition 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 MDR existing devices (so-called "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 the MDR transition period until 31 December 2027 for Class III and IIb implantable devices.
  2. Extension of the MDR transition period until 31 December 2028 for other devices of classes IIb, IIa and Im and Is as well as for devices classified as class I devices according to the directives, but whose conformity assessment procedure under the MDR requires the involvement of a notified body.
  3. Introduction of a transitional period until 26 May 2026 for Class III custom-implantable devices.
  4. Abolition of the "sales period" in the MDR (Article 120 (4)).

However, the extension is subject to several conditions to ensure that only safe products can benefit from the new transition period. Therefore, as a manufacturer, you must:

  1. establish a quality management system (QMS) compliant with the MDR by May 26, 2024; and
  2. submit a formal application for a conformity assessment procedure under the MDR to a Notified Body by 26 May 2024; and
  3. by 26 September 2024, a mutually signed written agreement must be entered into with their Notified Body for the conformity assessment procedure in accordance with the MDR.

In addition, the extension of the transitional regime only applies to existing MDD products that:

  1. continue to comply with Directive 93/42/EEC; and
  2. have no significant changes in interpretation or purpose; and
  3. do not pose unacceptable risks to the health and safety of patients and users.

The new regulation also includes an additional requirement for existing MDD products whose certification has already expired. These products can only benefit from the extended transition period if:

  1. you, as the manufacturer, have concluded a contract with a notified body for conformity assessment in accordance with the MDR before the expiry of the MDD certificate; or alternatively
  2. have benefited from an exemption under Article 97 or Article 59 of the MDR, which provides for exemptions from the applicable rules in certain cases

The extension of the transition period is in line with the demands of the medical device industry, which has long called for a more flexible deadline for the certification of existing MDD products, and is undoubtedly good news for affected medical device manufacturers. However, the need to meet the first deadline of 26 May 2024 requires swift action to ensure compliance with the new rules.

If you are interested or have any questions about this procedure, please do not hesitate to contact us.

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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