Medical Device Regulation - Proposed Extension of Transition Periods

During the 14 June 2022 Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Health Council concerns were raised regarding the challenges facing the implementation of Regulation (EU) 2017/745 (the Medical Device Regulation (MDR)) and the potential impact to the continued availability of certain medical devices on the EU market. Subsequently, at the 9 December 2022 EPSCO Health Council-¹, the European Health Commissioner, Stella Kyriakides, proposed an urgent, targeted legislative initiative to amend the transitional provisions provided for in Article 120 of the MDR².

The proposal received unanimous support at the 9 December 2022 EPSCO Health Council. The European Commission advised that the official legislative proposal, to extend the transition periods, would be made available at the beginning of 2023.

On 6 Jan 2023 the Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages³.

The central elements of the proposal, as it relates to the MDR, include:

Extension of the validity of certificates
Proposal Article 1(1)(a) amending MDR Article 120(2)

An extension will be directly applicable to devices, which have not been withdrawn by a Notified Body, and which have certificates issued by notified bodies in accordance with Council Directives 93/42/EEC or 90/385/EEC that were valid on the day of the MDR’s date of application i.e., 26 May 2021. The length of the extension of the certificate’s validity shall be linked to the device’s risk classification (refer to Extension of the Transition Period).

For devices whose certificates, issued under Council Directives 93/42/EEC or 90/385/EEC, are currently valid but will have expired by the time the proposed amendment comes into force; the extension will be subject to the condition that:
- Before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII
  or
- A Competent Authority has granted a derogation in accordance with Article 59(1)or has required the manufacturer, in accordance with Article 97(1), to carry out the applicable conformity assessment procedure within a specified time.
Extension of the transition period
Proposal Article 1(1)(b)⁴ amending MDR Article 120(3)

The proposed extension to the transition periods will apply to ‘legacy’ devices only; specifically, those devices covered by a declaration of conformity / certificate in accordance with Council Directive 93/42/EEC or 90/385/EEC issued before 26 May 2021. The duration of the extension will be based on device classification:
- Class III and Class IIB Implantable Devices⁵
  The transitional provisions under the MDR are to be extended to allow such devices to be placed on the market or put into service until 31 December 2027.
- Other Class IIB, IIa and Class I (sterile or measuring function) Devices
  The transitional provisions under the MDR are to be extended to allow such devices to be placed on the market or put into service until 31 December 2028.
- Devices up-classified under MDR (i.e., those not requiring involvement of a notified body under the MDD/AIMD and which now require notified body under MDR)
  The transitional provisions under the MDR are to be extended to allow such devices to be placed on the market or put into service until 31 December 2028.
These proposed extensions will be contingent on several cumulative conditions being met, specifically:
- Devices must continue to comply with Council Directive 93/42/EEC or 90/385/EEC.
- Devices must not undergo significant changes in the design and intended purpose.
- Devices must not present an unacceptable risk to the health or safety of patients, users or other persons.
- Manufacturers must have a Quality Management System (QMS), in accordance with Article 10(9), in place by 26 May 2024. No specific attestation i.e., no self-declaration nor verification of the appropriateness of the QMS by a notified body, is required at this stage.
Manufacturers/Authorised Representatives must have an application for conformity assessment in accordance with the MDR by 26 May 2024 for which a signed written agreement with the Notified Body must be in place by 26 September 2024.

Furthermore, as with the existing transitional requirements, the MDR requirements related to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply (in place of the corresponding requirements under Council Directives 93/42/EEC and 90/385/EEC) to devices availing of these extended transition periods.Class III custom-made devices may also avail of extended transition periods and be placed on the market or put into service until 26 May 2026 without the need for a certificate issued by a notified body in accordance with Article 52(8). The conditions attached to this extension require that by 26 May 2024 the manufacturer/authorised representative has lodged a formal application for conformity assessment and that by 26 September 2024 the notified body and the manufacturer have signed a written agreement.
Removal of the ‘sell-off’ deadline
Proposal Article 1(1)(c)⁴ amending MDR Article 120(4)

Under the existing transitional provision of the MDR, devices availing of the transitional provisions could continue to be made available or put into service until 26 May 2025.

This amendment proposed removing this time restriction such that devices placed on the market, in accordance with Council Directives 93/42/EEC or 90/385/EEC, prior to 26 May 2021 and devices placed on the market from 26 May 2021 which are availing of the extended transitional provisions can continue to be made available or put into service without a legal time restriction.

The proposal now needs to be adopted by the European Parliament and the Council through an accelerated ordinary legislative co-decision procedure.

The European Commission has now opened this proposal for stakeholder feedback6 with the feedback period having commenced 11 January 2023 with a deadline of 18 January 2023. This feedback will be presented to the European Parliament and Council to facilitate legislative debate.

West Regulatory Affairs is actively monitoring the latest with this evolving regulation and will communicate updates as they are available.

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