Commission Offers Glimpse Of Actions To Speed Up MDR Compliance

Article posted on 14 June 2022 on Medtech Insight
Author: Amanda Maxwell | Source of Original Article

Executive Summary

With a sense of desperation building among stakeholders over the challenges in ensuring all products are compliant with the Medical Device Regulation in time, high-level solutions are being considered. But a further MDR delay is not an option.


Hybrid notified body audits and coordinated market surveillance are among the measures that the European Commission has identified as possible actions to alleviate the current burden on notified bodies and improve the speed of compliance with the Medical Device and IVD Regulations

Stella Kyriakides, European commissioner for health and food safety, emphasized to the Council of the EU on 14 June that the commission will not allow a further delay of the MDR; a simple extension of the transition period “would not solve the problem, it would simply just postpone it,” she advised.

The commissioner was speaking at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting on 14 June, being held under the French council presidency, where she called for a coordinated and collective approach.

Kyriakides said that the commission’s proposed measures aim, among other things, to increase manufacturer preparedness and facilitate transition to the new regulations.

The EU cannot risk facing device shortages and so it is “extremely important that manufacturers get ready for the new requirements before the MDR transition period ends” on 26 May 2024, the commissioner insisted.

Citing the fact that more than 24,000 previously issued certificates will expire in May 2024, and that so far only 1,000 have been issued, she pronounced that it is not just manufacturers, however, that need to be prepared; all actors must work to ensure the deadlines are met in time, she stressed.

Not Just A Manufacturer Responsibility

Turning to the role of the commission, Kyriakides noted: “We need to do our part and ensure sufficient notified body capacity in the member states to ensure timely certification.” She added that the commission has initiated work by the Medical Device Coordination Group (MDCG) to agree on a list of actions to enhance notified body capacity and the preparedness of economic operators.

Other measures are under consideration, the commissioner said. One is that the certification of certain devices, such as orphan devices and of some legacy devices, will be accompanied by targeted conditions to alleviate the strain on the market.

All member states, she added, must allocate all necessary resources and provide political support to implement the necessary actions.

Kyriakides promised that the commission would continue to closely monitor the situation and be open to reviewing it again, in December, at the EPSCO meeting held under the Czech Republic presidency.

Member State Concerns

Member state representatives who spoke at the EPSCO meeting reflected manufacturers’ concerns about products becoming unavailable due to lack of notified body capacity and the risks of products not being certified in time and being removed from the market.

The Netherlands representative told the meeting that the MDCG has defined a “comprehensive action and mitigation plan.” Together, he said, member states should move towards a practical, endorsed plan as quickly as possible.

In the meantime, the representative suggested assigning leadership to one single actor.

Lithuania noted that member states are already receiving requests from manufacturers to apply temporary exemptions for placing their products on the market. If nothing changes, the number of requests will only grow, the representative said. Moreover, “if we fail to find adequate solutions we might face disruption of supplies, which in turn might compromise timely and safe provision of health care.”

The Sword Of Damocles

In the run up to the meeting, both the Competent Authorities for Medical Devices (CAMD) group and the Biomedicine Alliance In Europe issued statements reflecting their concerns about the lack of implementation readiness. The CAMD called for the MDCG to be tasked as a matter of urgency with seeking solutions to ensure a smooth MDR implementation. The Biomedicine Alliance In Europe warned of a “major clinical crisis” unless sufficient action is taken, and enough resources are made available.

But the MDCG also issued a position paper that seemed to point the finger of blame squarely at manufacturers for delays in implementing the MDR. In the text, the organization warned that unless companies can prove they have done the preparation work for the MDR compliance expected of them, including making their application to a notified body at least a year before their certificates were due to expire, they could find themselves in trouble.

Industry will now be waiting to hear some more encouraging news from the MDCG about what actions it will be taking and encouraging. But with the sword of Damocles hanging over it after the MDCG’s statements, no company would be advised to delay steps towards obtaining MDR certification now.


Author: Amanda Maxwell | Source of Original Article