MedTech Europe calls for a pause on IVDR and MDR implementation to facilitate the fight against COVID-19 and to safeguard healthcare systems
Posted on 02.04.2020
Helping healthcare systems to overcome the COVID-19 outbreak is the medical technology industry’s top priority and focus. To help ensure that needed medical technologies can remain available to the healthcare systems that need them, MedTech Europe has called on the EU institutions to temporarily pause the transition to the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
Shortly after this, on 25 March, the European Commission announced its intention to propose a 12-month postponement to the MDR’s date of application, via formal amendment of the Regulation. The legislative proposal is expected to start in early April. MedTech Europe remains convinced that a similar solution is still needed for the in vitro diagnostic sector, in the interest of keeping health systems up running effectively in times of the COVID-19 pandemic.
MedTech Europe’s statement regarding the Commission’s announcement can be found here.