Medical Technology Industry Voices Concerns in Open Letter to European Commission
In a significant development, the European medical technology industry has issued an open letter to the European Commissioner for Health and Food Safety, Stella Kyriakides, urging regulatory changes. The industry expresses its reservations regarding the current Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). There is growing apprehension that these regulations, which became effective in May 2017, are not progressing as expected.
Concerns Impacting Access, Innovation, and Costs
Prominent organizations, including MedTech Europe, Austro Med, and F Med, among others, have signed this open letter. They are concerned that the current regulations could potentially impede access to medical devices in the European market, stifle innovation, and escalate costs.
The open letter emphasizes that despite more than six years of implementation, the intended goals of the MDR and IVDR have not been fully realized. It further states, “There is a broad consensus that MDR and IVDR are causing certain products to no longer be available for medical care.”
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Proposed Areas for Regulatory Change
The letter outlines three key areas for regulatory reform:
- Efficient CE Marking System: The industry advocates for a more streamlined and effective CE marking system to facilitate the approval process for medical devices.
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- Support for Innovation: A system that actively supports innovation in medical devices and diagnostics is proposed to foster progress in the field.
- Single Regulatory Oversight Structure: The letter calls for the establishment of a single, dedicated accountable entity to oversee and manage the regulatory system, aiming for greater coherence and efficiency.
Industry Concerns Echoed at Conference
During the Outsourcing in Clinical Trials: Medical Devices Europe 2023 conference held on February 21-22 in Munich, concerns similar to those expressed in the open letter were discussed. Philips clinical project manager Deborah Ann Schuster highlighted the increasing challenges in complying with EU MDR requirements for the submission of technical documentation, which she described as time-consuming and resource intensive.
Acknowledgment and Call for Collaboration
Despite critiquing the structural issues within the regulatory framework as “unpredictable, complex, slow, and costly,” the letter commends Commissioner Kyriakides for her comments in the December 9, 2022, EPSCO meeting. It encourages her to continue advocating for structural reform in Europe’s health policy discussions and offers support to collaborate with the European Commission to address these regulatory challenges.
Request for Dialogue and Reform
The letter concludes by requesting a meeting with the European Commission to discuss structural reforms within the regulatory system. The aim is to find solutions that enhance efficiency, stimulate innovation, and improve governance in the European medical technology industry.
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