Whole EU Medtech Industry Behind Latest Push To Have MDR Problems Tackled At Highest Levels

Article posted on 28 October 2022 on Medtech Insight
Author: Amanda Maxwell | Source of Original Article

Executive Summary

The number of attempts to persuade EU decision-makers to take radical action to alleviate the MDR implementation pressures is growing exponentially as voices turn into a loud clamor for change.


The whole EU medtech industry is now galvanizing support at every level to ensure there is action to stop the MDR impacting product availability. 

Nearly 300 CEOs from leading medtech companies have sent a letter to all ministers of health across Europe, as well as to key figures in the European Parliament, demanding legislative action to resolve the lack of sufficient MDR certification and the resulting lack of availability of medical devices and IVDs in Europe.

This is the latest in a growing number of attempts to drive home the message not only to the European Commission, but also to co-legislators at the Council of the EU and European Parliament, that action needs to be urgently taken to stop products permanently disappearing from the market and put an end to the delay in certification of new and improved products.

The MDR’s problems and possible solutions are expected to be discussed at the meeting of Europe’s Employment, Social Policy, Health and Consumer Affairs Council, on 8-9 December. So bringing these matters to the attention of health ministers across the EU is a strong pre-emptive strike.

The industry’s letter calls for legislative action to:

  • Extend the validity of the current certificates issued under the Medical Devices Directive and the Active Implantable Medical Devices Directive in a similar manner to the January 2022 amendment to the IVDR Regulation, and so with different deadlines for each risk class.
  • Allow conditional/temporary certification to maintain access to existing devices, substantially changed and new devices, for example by allowing time to finish compiling further data/evidence needed to meet the MDR requirements.
  • Abolish the MDR Article 120(4) warehousing deadline to allow the continued sale of existing devices beyond the May 2025 end-date, provided they are manufactured before 26 May 2024. This will avoid needless disposal of devices already on the market.

19-Point Plan Insufficient

The signatories recognize that the Medical Device Coordination Group proposed 19 non-legislative measures in its MDCG 2022-14 paper earlier this year but say these are “insufficient” and “fail to address the growing emergency of expiring certifications.”

They also fail to provide a workable regulatory pathway for new devices whose technological innovation can bring needed solutions to Europe’s pressing health care challenges, they say.

“Unless immediate action is taken,” the letter states, “Europe faces a scenario where a high number of existing medical devices, upon which patients, hospitals and other health institutions rely, will fail to be re-certified on time and therefore risk permanently disappearing from the market. At the same time, certification of new and improved products is also delayed, resulting in delayed patient access to the benefits of innovation.”

The letter also emphasizes the importance of working to strengthen the role of Europe as an attractive region for investment in medical technology innovation. This could be achieved, it suggests, by setting as a priority, timely patient access to best-in-class breakthrough technologies which address unmet medical needs through clear regulatory pathways.

Infographic Clearly Demonstrates Issues

Concurrently, MedTech Europe, the EU’s largest medtech industry association, has published an Infographicwhich is being widely distributed on LinkedIn and graphically highlights the problems in a manner easily accessible to all.

Written information contained in the Infographic repeats the same legally binding solutions as the letter to member states and calls for further work and clarity on existing measures to:

  • Leverage and reuse evidence from previous assessments.
  • Adopt more pragmatic clinical evidence expectations.
  • Grant manufacturers early dialogue opportunities with notified bodies.
  • As a last resort, make EU-wide derogations more workable.

Author: Amanda Maxwell | Source of Original Article

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