The Regulation (EU) 2023/607 introduces a staggered extension of the transition period provided for in the MDR, which is yet subject to certain conditions being met. The new deadlines depend on the risk classification of the respective medical devices. It also deletes the "sell-off" deadline, after which devices placed on the market before or during the transition period that are still in the supply chain would have had to be withdrawn.
The Regulation only amends the transitional provisions to give manufacturers more time to transition to the new requirements of the MDR. It is yet important to highlight that the current safety and performance requirements in the MDR are not changed in this amendment.
Of extreme importance is also that the extensions are not applied to every medical device. According to paragraph 2 of Article 120 of the Regulation, the extensions are only applied to medical devices covered by a certificate issued from 25 May 2017 and that is still valid on 26 May 2021 and which has further not been withdrawn afterwards. Or by a certificate issued from 25 May 2017 that is still valid on 26 May 2021, and which has expired before 20 March 2023. The transition period to the new rules is extended depending on the risk classification, which is outlined in paragraph 3a and 3b of Article 120 as follows:
● Devices which have a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid under paragraph 2 of Article 120:
(a) For all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors may be placed on the market until 31 December 2027.
(b) For class IIb devices other than those covered by point (a), for class IIa devices, and for class I devices (sterile and/or with measuring function) may be placed on the market until 31 December 2028.
● Up-classified devices that require notified body involvement in the conformity assessment according to the MDR may be placed on the market until 31 December 2028.
The extension will be subject to certain conditions in paragraph 3c of the Article 120 of the Regulation (EU) 2023/607, including:
(a) A continuous compliance with Directive 90/385/EEC or Directive 93/42/EEC is required.
(b) There shall be no significant changes in the design and intended purpose of the MDD product.
(c) There shall be no unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health.
(d) The manufacturer’s quality management system shall be in place in accordance with the MDR by 26 May 2024 at the very latest.
(e) A formal application for MDR conformity assessment should have been made by 26 May 2024 and a contract between the manufacturer and the selected notified body shall be in place by 26 September 2024.
Furthermore, there are also specific conditions for certifications that have already expired. In such cases, the following conditions shall be met:
● The manufacturer shall have a contract for MDR certification signed with a notified body before the certificate’s expiry, or
● A National Competent Authority (NCA) shall have granted an Article 59 MDR derogation or 97 MDR application, respectively.
Apart from the extension for devices mentioned above, paragraph 3f introduces a transition period until 26 May 2026 for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024 and an agreement between the manufacturer and the selected notified body shall be signed by 26 September 2024.
Moreover, to reflect the transition periods put forward by these amendments, the Regulation extends the validity of certificates issued up until 26 May 2021 (the day when the MDR became applicable).
Furthermore, the “sell-off” date currently established in the MDR and in the IVDR is removed. The “sell-off” date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this “sell-off” date will ensure that safe and essential medical devices already on the market remain available to healthcare systems and patients in need.
Nonetheless, it is worth noting that according to paragraph 3d of Article 120, the requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in paragraphs 3a and 3b of this Article in place of the corresponding requirements in Directives 90/385/EEC and 93/42/EEC.
For further details of the amendment, please consult the reference below.
● REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices