In 2017, the EU adopted new regulations to replace the Medical Device Directive (MDD). These regulations, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) are more comprehensive and demanding than the original MDD, with a stronger focus on product safety, cleanliness, and post-market monitoring.
Under MDR, certificates issued under the MDD prior to the full application of the MDR on 26th May 2020, will remain valid for a period of up to four years until 26th May 2024. During this transitional period, devices that comply with the MDR can be certified under the new regulation and made available for sale in the market.
The new Medical Device Regulation was made in response to the growing frequency of failure of medical devices, and an increased need for transparent technical information. Initially, the transition time was scheduled to end on the 26th May 2024. However, several industry investors and opinion leaders have expressed concern that the deadline will negatively impact on the availability of many medical devices required by patients and healthcare providers across the EU. Additionally, opinions suggested that the previously proposed transitional time posed a threat to research and innovation. This is because, although MDR is not a complete change from the rules set out by MDD, it requires companies to make significant changes in order to comply.
In addition to the strong backlash from stakeholders, limitations in the capacity of Notified Bodies were also a significant factor in calls for an extension to the transition period.
On 6 January 2023, the Commission proposed extending the certification timeline for medical devices to prevent potential shortages, and add a longer transition period to comply with the MDR rules. The new timelines vary based on the risk class of the medical device and guarantee patient access to medical devices. Additionally, the proposal allows medical devices already on the market under current legal regulations to stay on the market without a “sell-off” date, meaning devices that have already been approved under MDD will still be available.
This proposal was introduced to ensure access to safe medical devices for patients across the EU. It does not alter existing safety and performance standards outlined in the MDR. It only modifies the transition provisions to provide additional time for manufacturers to adjust to the new regulation requirements.
The length of the extended transition period varies based on device type: higher risk devices, such as pacemakers and hip implants, have a shorter transition period (until December 2027). For medium and lower risk devices, such as syringes or reusable surgical instruments, the transition period is longer (until December 2028).
What happens next?
The proposal has been embraced by many, but it still needs to be approved by the European Parliament and Council as part of an accelerated co-decision procedure.
Despite the proposed extension to the transition period, active players in the medical device industry in the EU such as manufacturers, importers, distributors, must closely monitor the Commission’s legislative process, including any changes to the proposal until it is approved by Parliament and the Council. It is also crucial to keep track of any guidance provided for implementing the proposal if and when it becomes law.
Working with a CRO that understands the EU MDR and its impact on research is important. At Clinicology, we advise our clients on strategies for medical device trials as part of our high quality services to ensure your trial reaches its goals. To find out how we can help you, please contact firstname.lastname@example.org or call +44 (0) 1483 977 777.