- Life Sciences
EU Parliament adopts amendments to EU MDR and IVDR Transition Rules
20 February 2023
The amendments largely follow the key points presented by the European Commissioner for Health and Food Safety, Stella Kyriakides, in December 2022 (see our blogpost here), aiming to prevent shortages of medical device supply resulting from the lack of notified bodies and the tight deadlines of the MDR.
Medical device manufacturers will benefit from the following amendments:
Amendments to the MDR
- Extension of the transition periods for devices covered by a CE certificate issued according to the Medical Device Directive (MDD) or the Active Implantable Device Directive (AIMDD) prior to 26 May 2021:
- 31 December 2027 for class III devices and most class IIb implantable devices;
- 31 December 2028 for other class IIb devices, class IIa devices and class Is or Im devices.
- These extended transition periods apply only if the following conditions are met:
- The device continues to comply with the MDD/AIMDD;
- The device has not undergone any significant changes in its design or intended purpose;
- The device does not present an unacceptable risk to the health and safety of patients and users;
- By 26 May 2024, the manufacturer has put in place a quality management system according to Art. 10(9) MDR; and
- By 26 May 2024, the manufacturer has lodged a formal application for the conformity assessment according to the MDR and, by 26 September 2024, has signed a written agreement with a notified body on the conformity assessment according to the MDR.
- Extension of MDD/AIMDD certificates until the end of the respective transition period (as above) – this applies even for certificates which have expired before the amendments will have entered into force, if:
- The manufacturer and a notified body have signed a written agreement on the conformity assessment of the device covered by the certificate; or
- A national competent authority has granted a derogation from the applicable conformity assessment procedure according to Art. 59(1) MDR or has required the manufacturer to carry out a conformity assessment procedure within a certain time period according to Art. 97(1) MDR.
- Introduction of a new transition period for class III custom-made implantable devices until 26 May 2026 – the current transition periods do not cover these devices. This transition period applies if the manufacturer has lodged a formal application for the conformity assessment according to the MDR and, by 26 September 2024, has signed a written agreement with a notified body on the conformity assessment according to the MDR.
- Removal of the sell-off date (currently 27 May 2025) for devices placed on the market according to the transition periods of the MDR – there will be no time restriction for making these devices available on the market after the end of the transition periods.
Amendments to the In Vitro Diagnostics Regulation (IVDR)
- Removal of the sell-off date (currently between 26 May 2025 and 26 May 2028, depending on the risk class of the device according to the IVDR).
No extension of the transition periods. Generally, devices with a certificate issued in accordance with IVDD may be placed on the market until 26 May 2025. Devices for which the conformity assessment procedure pursuant to Directive IVDD did not require the involvement of a notified body may be placed on the market until 26 May 2027, depending on the classification of the device. (see also our blogpost referring to the proposed amendment of the IVDR here).
Medical device manufacturers, whose MDD/AIMDD certificates will still be valid, when the amendments enter into force, will not have to take immediate actions in general. However, manufacturers should focus on two objectives, if they have not already done so: (i) contacting a notified body and signing a contract regarding the MDR conformity assessment, which is especially important, as the amendments will not resolve the lacking capacities of notified bodies and (ii) setting up a MDR quality management system. Both of these actions have to be taken before 26 May 2024 to benefit from the new transition rules.
Manufacturers with already expired MDD/AIMDD certificates can also apply for the procedure under Art. 97 MDR, provided they fulfil the requirements set forth by the Medical Device Coordination Group (MDCG). In specific cases, applying for a derogation according to Art. 57 MDR might also be an option, even though this provision is not supposed to serve as a solution for delayed MDR conformity assessment procedures according to the MDCG.