In an open letter addressed to the European Commissioner for Health and Food Safety, Stella Kyriakides, the medical technology industry has called for change in the current regulation.
The open letter addresses the industry’s concerns with the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). There are fears that the MDR and IVDR are not on track to meet the outlined goals of the regulation since they came into effect in May 2017.
The conglomerate who signed this letter which includes MedTech Europe, Austro Med, F Med and many more, believe the regulations could delay access to devices in the European market, hinder innovation, and drive-up cost.
The letter to the European commission stated: “Despite more than six years of implementation, these goals are still not fully achieved.” It added “There is a broad consensus that MDR and IVDR are causing certain products to no longer be available for medical care.”
According to the letter, the issues are affecting both on the market and future innovation devices from reaching European patients and health systems.
The letter advises three areas for change - a more efficient and fit-for-purpose CE marking system, a system that supports innovation for medical devices and diagnostics, and a single, dedicated accountable structure to oversee and manage the regulatory system.
These concerns were also brought up during the Outsourcing in Clinical Trials: Medical Devices Europe 2023 conference on Feb 21-22 in Munich. Philips clinical project manager Deborah Ann Schuster said: “Now the requirements for the submission of technical documentation to begin these trials is way more challenging. EU MDR requires the innovators to prepare time-consuming documentation and they need much more manpower and funding to comply with the regulations.”
Despite calling for change to the structural issues in the regulatory framework which the letter labels “unpredictable, complex, slow and costly”, the letter did praise Kyriakides for her comments in the 9 December 2022 EPSCO meeting. The letter urges her to continue to champion structural reform within Europe’s health policy debates and offers support to work with the European Commission to address these regulatory challenges.
The letter ended with a request for a meeting to discuss structural reform of the regulatory system, and provide a solution to improve efficiency, innovation, and governance.
