The European Commission Proposes to Extend the Transition Deadline in the EU Medical Device Regulation
… a major change to the Regulation is needed to prevent shortages of life-saving medical devices…
On Friday 9 December 2022, the European Commission proposed to extend the transition deadline in the Medical Device Regulation (EU) 2017/745 (MDR). According to the European Commissioner for Health and Food Safety, Stella Kyriakides, a major change to the Regulation is needed to prevent shortages of life-saving medical devices, from implants and prosthetics to ventilators and pacemakers.
Medical devices in the EU are regulated under the MDR, and the MDR replaced the previous Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) on 26 May 2021. Currently, medical devices can be placed on the EU market under a CE mark certificate issued under the MDD or AIMDD until 26 May 2024 (Transition Deadline). After the Transition Deadline, these products will require a CE mark certificate issued under the MDR so that they remain available on the EU market – a potentially costly and time-consuming process.
A broad range of stakeholders in the medtech sector consider the Transition Deadline to be unattainable. The pandemic, shortages of raw materials caused by the conflict in Ukraine and low Notified Body capacity have collectively put a strain on the ability for medical device manufacturers to meet the Transition Deadline. Without an extension to the Transition Deadline, it is anticipated that a significant number of medical device manufacturers would need to take their products off the EU market due to an inability to comply with the new requirements under the MDR within the required timeline.
The European Commission has proposed the following legislative amendments:
- Extension of the Transition Deadline in the MDR based on the risk class of each device:
- 26 May 2027 for Class III and Class IIb medical devices; and
- 26 May 2028 for Class IIa and Class I medical devices.
- Extension of the validity of CE mark certificates issued under the MDD and AIMDD if needed for legal and practical reasons (e.g. to access markets outside of the EU that accept products with a CE mark), provided that:
- the device does not present an unacceptable risk to health and safety;
- the device has not undergone significant changes in design or intended purpose; and
- the manufacturer has already undertaken the necessary steps to launch the CE mark certification process under the MDR (e.g. lodged an MDR application with a Notified Body by 26 May 2024).
- Elimination of the “sell-off” date under the MDR and under the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) to avoid safe medical devices and in vitro diagnostics (e.g. blood glucose meters) that are already on the EU market from having to be discarded by 27 May 2025.
The European Commission intends to provide these legislative amendments to the EU legislature for consideration at the beginning of 2023.
The European Commission also intends to undertake a comprehensive evaluation of the MDR by May 2027. The purpose of the evaluation is to identify structural problems with the MDR and potential medium and long-term solutions to these concerns.
As a final note, except for the elimination of the “sell-off” date, none of the proposed legislative amendments applies to in vitro diagnostics. Given that there are still few Notified Bodies under the IVDR, similar amendments might also be required for in vitro diagnostics in the near future.