European Commission Grants More Time to Certify Medical Devices

Medical device manufacturers get additional three or four years, depending on risk class

Published: Friday, January 6, 2023 - 09:53

In a press statement released on Jan. 6, 2023, the European Commission reported the adoption of a proposal to allow more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation (MDR).

According to the commission, the new deadlines depend on the medical devices’ risk class and will ensure continued access to medical devices for patients. It will also allow medical devices placed on the market in accordance with the current legal framework and that are still available to remain on the market (i.e., no “sell-off” date).

“Our rules on medical devices will always prioritize patient safety and support for innovation,” says Stella Kyriakides, EU Commissioner for Health and Food Safety. “A combination of factors has left healthcare systems across the EU facing a risk of shortages of life-saving medical devices for patients. Today, we propose a revised regulatory timeline to provide certainty to industry in order to continue producing essential medical devices, reducing any short-term risk of shortages, and safeguarding access for patients most in need.”

The proposal doesn’t change any of the current safety and performance requirements provided for in the MDR. It only amends the transitional provisions to give more time for manufacturers to transition from the previously applicable rules to the new requirements of the regulation. 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) than medium- and lower-risk ones, such as syringes or reusable surgical instruments (until December 2028).

Key elements of the proposal

For medical devices covered by a certificate or a declaration of conformity issued before May 26, 2021, the transition period to the new rules is extended from May, 26, 2024, to December 31, 2027, for higher-risk devices, and until December 31, 2028, for medium- and lower-risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the MDR will benefit from the additional time.

The proposal introduces a transition period until May 26, 2026, also for class III implantable, custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before May 26, 2024.

To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until May 26, 2021, the day when the MDR became applicable.

The commission also proposes to remove the sell-off date currently established in the MDR and in the In Vitro Diagnostic Medical Devices Regulation (IVDMR). The sell-off date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this sell-off date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.

Next steps

The proposal now needs to be adopted by the European Parliament and the council through an accelerated co-decision procedure.

“I call on the European Parliament and the Council to quickly adopt the proposal,” says Kyriakides. “Member states and notified bodies should also work with industry to ensure transition to the new rules provided for by the Medical Devices Regulation without further delay.”

Background

Medical devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. In April 2017, the European Parliament and the council adopted Regulation (EU) 2017/745 and Regulation (EU) 2017/746 to reinforce the regulatory framework for medical devices and in vitro diagnostic medical devices.

They aim to provide a high level of health protection for patients and users, and the smooth functioning of the internal market for these products. To achieve these objectives and in light of issues identified with the previous regulatory framework, the regulations set out a more robust system of conformity assessment to ensure the quality, safety, and performance of devices placed on the EU market. The Medical Devices Regulation has been applicable since May 26, 2021. It provides for a transition period until May 26, 2024.

At the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on December 9, 2022, EU ministers of health called on the commission to swiftly submit a proposal to extend the transition period in the MDR. The proposal will now be negotiated by the European Parliament and the council.

For more information

Questions and Answers

Factsheet European Health Union: Supporting the transition to the new medical device framework. Proposal for a regulation amending Regulation (EU) 2017/745.

Medical Devices—New Regulations

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