03.04.2020 – 15:57
EU Commission wants to postpone MDR implementation by one year
Swiss Medtech considers the postponement essential to ensure patient care
In view of the coronavirus pandemic, Swiss Medtech considers the EU Commission proposal to postpone the Medical Devices Regulation (MDR) date of application by one year to be imperative. The Association hopes that the Council and Parliament will also promptly agree with the recommendation. Ensuring the supply of medical devices required for the general population is now top priority.
Even prior to the corona pandemic outbreak, a timely Europe-wide implementation of MDR would barely have been achievable. It has now become impossible. In addition to the previously recognized problems - too few test centres, capacity problems with recertification, insufficient personnel trained for regulatory issues, and delayed introduction of the central Eudamed database - the outbreak of the coronavirus has added further difficulties; forcing test centres to close or restrict their activities. And this at a time when the medtech industry must secure supply chains and increase production capacity in order to meet the growing demand for medical devices.
In view of the corona pandemic, Swiss Medtech considers the EU Commission's proposal to postpone the implementation of MDR by one year to 26 May 2021 to be essential. «Our health system is currently fighting one of the worst pandemics of the last 100 years. The medical technology industry must now be free to focus on helping manage the corona crisis. From an epidemiological point of view, it is unimportant if well-proven medical devices bear an old or a new certificate next May. It is much more imperative that the products are available. This now has top priority», says Peter Biedermann, Managing Director of Swiss Medtech.
Provided that the Council and Parliament follow the EU Commission proposal, medical devices may continue to be marketed under the current legal framework within the EU Single Market until 26 May 2021.
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