It has been announced that the European Commission has postponed the date of application of the Medical Devices Regulation (MDR). Originally scheduled to go into effect May 26th, 2020, it will now be implemented a year later on May 26th, 2021.
With pressure mounting from the impact of COVID-19, a proposal by the European Commission to delay the full implementation of MDR gained 693 votes to one, and two abstentions, on 17th April from the European Parliament.
The Impact of Coronavirus on MDR
The European Parliament stated, “Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the Medical Devices Regulation from May this year.”
With increased demands for vitally important medical devices during this time, it is vital that any potential disruptions are avoided. By continuing under current procedures, the fight against COVID-19 is prioritised and the availability of safe and essential medical devices is ensured.
Benefits of Postponed MDR
Postponing the MDR application gives manufacturers and other industry players more time to focus on urgent priorities regarding the coronavirus. Relieving the pressure of implementing new regulations means medical devices can be sold for another year and single-use devices (SUDs) can still be reused in-house.
Additionally, the medical device industry and regulatory bodies can use this time to fully prepare and ensure they are ready for MDR. An overview of the requirements and suggested preparation methods are available in our previous MDR blog article.
BDK provides complex manufacturing and assembly solutions with engineered adhesive components. We are a leading European adhesive tape converter using flexible materials and adhesive coated materials. We maintain high standards and recognise that being aware of changing requirements within our industry is vital.