Elizabeth Anne Wright, partner, and Anastasia Vernikou, legal trainee, at law firm Cooley explain the practicalities of any proposed revision to the EU Medical Device Regulation (MDR).
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Medical Device Regulation
The growing challenges faced by a range of stakeholders within the medical device space has led the European Commission to submit a proposal to revise the Regulation (EU) 2017/745 on medical devices (MDR) to extend the transitional periods foreseen by the Regulation. During the EPSCO Council meeting on Friday 9 December 2022, the European commissioner for Public Health and Food Safety, Stella Kyriakides, underlined the need for swift legislative action to avert the risk of disruption to the availability of medical devices in the EEA. Most EU member states health ministers welcomed the proposed amendments and acknowledged the urgent need to extend the transitional periods established in the MDR.
The European Commission’s proposes extension of the transitional period of the MDR
The current transitional periods provided in the MDR require medical devices for which CE certificates of conformity have been issued in accordance with the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD) (the Directives) to be re-certified on the basis of the MDR by 26 May 2024. Devices that are not re-certified by this date may not lawfully be placed on the EEA market. In any event, all CE certificates of conformity issued on the basis of the Directives will expire by 26 May 2024 at the latest.
According to the Information Note published prior to the EPSCO meeting:
- Approximately 6% of the 22,793 certificates issued under the Directives will have expired by the end of 2022
- 19% will expire in 2023; and
- The remaining 75% in the first five months of 2024.
Given the number of expiring certificates and the current over-subscription faced by notified bodies designated to the MDR there is growing risk that these devices will not be re-certified before the end of the current transition period. The European Commission has consequently proposed to extend the transition period provided in Article 120.3 of the MDR based on the risk classification of each device. According to the Commission’s proposal:
- The extent to which the transition period will be increased will depend on the risk classification of devices:
- High risk devices (Class III and Class IIb) will be required to conform to the MDR by 2027 at the latest
- Medium and low risk devices (Class IIa and Class I) will be required to conform to the MDR by 2028 at the latest
- The sell-off date currently provided in Article 120.4 MDR will be removed. As a result, devices previously placed on the EEA market on the basis of CE certificates of conformity issued by the Directives may remain on the EEA market.
The limitations imposed on benefit from the transitional period provided in the MDR will remain. The device must not have undergone significant changes in design or intended purpose nor present an unacceptable risk to health and safety. The manufacturer must also have commenced the steps necessary for compliance of the device with the MDR before the required related deadline.
Additional, non-legislative measures proposed
In addition to the targeted legislative measures proposed by the European Commission, a position paper on the application of Article 97 of the MDR prepared by the Medical Device Coordination Group (MDCG) was published following the EPSCO Council meeting. The purpose of the paper is to ensure a uniform approach to the application of market surveillance measures to bridge the gap between expiry of CE certificates of conformity issued on the basis of the Directives and the issuance of new certificates on the basis of the MDR. Although it is non-binding the paper provides guidance concerning extension of the validity of CE certificates issued on the basis of the Directives that, experience suggests, will be respected.
Moreover, the European Commission has announced its intention to undertake a comprehensive assessment of the MDR by May 2027. The purpose of the evaluation is:
- To identify structural problems within the Regulation;
- Assess whether the Regulation has achieved its legislative purpose or has had a negative impact on patient safety, public health or medical innovation; and
- Propose potential medium and long-term solutions to these concerns.
Next Steps
EU Commissioner for Health and Food Safety, Stella Kyriakides, has stated that the European Commission legislative proposal will be provided to the European Council and European Parliament for consideration in early 2023.
The European Commission also intends to fund actions to support the implementation of the MDR under the EU4Health Programme starting in early 2023 and to provide solutions for orphan devices.
The European Commission’s proposal is a necessary step towards mitigating the risk of compromising patient access to certain life-saving medical technology. However, it remains to be seen if the proposal to the European Council and European Parliament will address outstanding issues, including the extension of the validity of CE certificates and the removal of the sell-off point for in vitro diagnostic medical devices falling within the in vitro diagnostic medical devices Regulation.
