European Commission proposes to extend MDR transition periods to prevent shortages in medical devices
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Currently, medical devices can be placed on the EU market under CE certifications issued according to Directive 93/42/EEC (MDD) or 90/385/EEC (AIMDD) until 26 May 2024 at the latest. After this transition period, these products will require certification under the MDR. According to the European Commission, notified bodies will have issued approximately 7,000 certificates under the MDR by May 2024. In contrast, there are 22,793 valid CE certificates issued under Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD) and a considerable number of self-certified devices under the MDD/AIMDD, which will also require certification by a notified body under the MDR. A large number of medical devices manufacturers has already withdrawn their products from the market or plans to reduce their product portfolio at the end of the transition period.
Therefore, this deadline has already been strongly criticised over the last few years by several stakeholders and politicians. Recently, France, Germany and Ireland have submitted a so called “non-paper” to the EC demanding the extension of the deadline. As all mitigating measures proposed by the Medical Device Coordination Group (MDCG), e.g. in Position Paper MDCG 2022-14, have turned out to be insufficient, the European Commission has reversed its position and recognised the need for legislative measures in order to prevent shortages in medical devices.
European Commission’s proposals
At the EPSCO Council meeting, the European Commission presented the key points of its intended legislative initiative to amend the MDR:
- Extension of the transition period in Article 120(3) MDR (May 2024) with staggered deadlines depending on the risk class of the device:
- 2027 for Class III and Class IIb devices; and
- 2028 for Class IIa and Class I devices requiring the involvement of a notified body in the conformity assessment;
- Extension of the validity of certificates issued under the MDD and AIMDD, which was mentioned in the information note prior to the meeting; and
- Removal of the “sell off” provisions in Article 120(4) MDR and Article 110(4) In Vitro Diagnostic Regulation (IVDR).
These extensions shall only apply to devices: (i) which do not present any unacceptable risk to health and safety; (ii) which have not undergone significant changes in design or intended purpose; and (iii) for which manufacturers have already undertaken the necessary steps to launch the certification process under the MDR.
The European Commission plans to prepare the legislative proposal by the beginning of 2023. Given the fact that the EPSCO Council members have broadly supported the proposals presented at the meeting, the amendments may enter into force in short order.
Short term solution: Article 97 MDR
However, there is still a need for immediate measures for those medical devices whose CE certificates under the MDD/AIMDD will expire before the amendments to the MDR enter into force and which have no CE certification under the MDR yet. Therefore, the MDCG has published its Position Paper MDCG 2022-18, focussing on the application of Article 97 MDR to legacy devices for which the MDD/AIMDD certificate will expire before the issuance of a MDR certificate.
- the manufacturer has already taken steps to obtain the certification under the MDR (e.g. the manufacturer’s application for conformity assessment has been accepted by a notified body and a written agreement between the notified body and the manufacturer has been signed);
- the device has not undergone a significant change in its design or intended purpose; and
- the device does 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 (this will be assessed e.g. based on the manufacturer’s post-market surveillance system and on available vigilance and market surveillance data).
In these cases, the competent authority (CA) of the Member State where the manufacturer or its authorised representative has its registered place of business shall define a period during which the manufacturer must bring the device into compliance with the MDR, but is still allowed to place the device on the market. Generally, this period shall not exceed 12 months, but may be extended in individual cases. The CA is also responsible for issuing a written communication on the defined period and informing the CAs of the other Member States of its decision in order to avoid diverging periods in the Member States.
The application of Article 97 MDR does provide a short-term solution, but cannot serve as a solution for the structural problems of the MDR, in particular resulting from the lack of notified bodies.
Side note: In vitro diagnostics
Besides the removal of the “sell-off” provision in Article 110(4) IVDR, neither the European Commission’s proposals nor Position Paper MDCG 2022-18 apply to (legacy) in vitro diagnostics. However, as there are still few notified bodies under the IVDR, the transition period of the IVDR, which was already extended in January 2022, might not be sufficient. Therefore, similar amendments might also be required for in vitro diagnostics in the near future.