MDR/IVDR New Proposal

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MDR/IVDR New Proposal

By Evangelia Manika, LL.B MSc Associate
March 2023

On 6 January 2023, the Commission adopted a proposal regarding the transitional provisions for certain medical devices and in vitro diagnostic medical devices, in order to give more time to certify medical devices to mitigate the risk of shortages. The transition to the new rules has been slower than initially estimated. COVID-19 pandemic and limited capacities of notified bodies are among factors in slow transition to the new regulatory framework. In addition, many manufacturers are not sufficiently prepared to meet the strict requirements of the MDR by the end of the current transition period. This threatens the availability of medical devices on the EU market.

In this context, the proposal introduces a longer transition period to adapt to new rules in order to give more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulations. The extended transition period applies only to ‘legacy devices‘, i.e. those covered by a certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before 26 May 2021. Moreover, the application of the extended transition period will be subject to certain conditions in order to ensure that only devices that are safe and for which manufacturers have already taken steps to transition to the MDR will benefit from the additional time.

In particular, the new deadlines depend on the medical devices’ risk class and will ensure continued access to medical devices for patients. The length of the proposed extension of the transition periods depends on the type of device: higher risk devices such as pacemakers and hip implants will benefit from a shorter transition period (until December 2027 – from the current 26 May 2024 deadline) than medium and lower risk ones, such as syringes or reusable surgical instruments (until December 2028).

Moreover, the proposal introduces a transition period until 26 May 2026 also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Those devices are currently not covered by the Regulation’s transitional provisions.

The proposal also aims at removing in both MDR and IVDR the ‘sell-off’ deadline (27 May 2025 according to MDR, 25 May 2025 to 26 May 2028 according to IVDR) after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off’ deadline will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients most in need.

The new proposal does not change any of the current safety and performance requirements provided for in the MDR, which aims to provide a high level of health protection for patients and users. This means that the application of the entire Regulation is not postponed since the MDR has been applicable since 26 May 2021 and remains applicable.

The proposal now needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure. It is important for the MedTech companies to continue to transition to the MDR and IVDR as soon as possible in order to be compliant with the new stricter medical devices’ regime.