Medical devices: extension of the transition period

As you may know, the MDR is applicable since 26 May 2021 and provides for a transition period allowing economic operators to place on the market medical devices benefiting from certificates of conformity issued in accordance with the Medical Device Directives (MDD) until 26 May 2024.

Many manufacturers and associations had pointed out the impossibility to obtain an MDR certificate of conformity at the end of the transitional period initially provided for, in particular with regard to the insufficient evaluation capacity of the notified bodies, and therefore were planning to reduce their product portfolio at the end of the transitional period.

On 13 January 2023, the Commission adopted a proposal to extend the above mentioned transition period for devices covered by a certificate or declaration of conformity issued before 26 May 2021.

• The transition period is then extended as follows:

  • 31 December 2027 for high risk medical devices: class III devices and class IIb implantable medical devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors);

  • 31 December 2028 for medium and low risk medical devices: certain class IIb devices, class IIa devices and for class I devices placed on the market in sterile condition or having a measuring function.

    Nevertheless, the application of this extension of the transitional period is subject, in the proposed amendment, to certain cumulative conditions:

  • the conditions already included in Article 120(3) of the MDR:

    • the devices must comply with Directive 90/385/EEC or Directive 93/42/EEC, as the case may be;
    • the devices must not be subject to significant changes in the design and intended purpose;

  • the devices must not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;

  • the manufacturer must implement a quality management system no later than 26 May 2024;

  • the manufacturer, or an authorized representative, must have lodged an application for the conformity assessment of its device by 26 May 2024;

  • the manufacturer and the notified body must have signed a written agreement by 26 September 2024.

In addition, the requirements of the MDR related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices apply to the concerned devices.

• Moreover, the Commission proposes to introduce a transitional period for Class III custom-made implantable devices that could then be placed on the market or put into service until 26 May 2026 without a certificate issued by a notified body provided that the manufacturer, or its authorised representative:

  (i) has submitted an application for the conformity assessment of its device no later than 26 May 2024 and;

  (ii) has signed an agreement with a notified body no later than 26 September 2024.

Lastly, the text also removes the "sell-off period" date currently set in both the MDR and the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). This is the date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn.

This amending Regulation should now be adopted by the European Parliament and the Council.

Please note that the European Commission has initiated a consultation concerning the extension of this transition period (opened from 11 January to 18 January 2023) which is available via the following link: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Extension-of-the-transition-period-for-medical-devices_en