6 April 2020

On Friday 3 April the European Commission has adopted a proposal amending Regulation (EU) 2017/745 on medical devices as regards the dates of application.

In order to allow Member States and medical industry to prioritise the fight against the COVID-19 pandemic, the application of the EU MDR is postponed by one year – until 26 May 2021.

In this exceptionl crisis context, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of safe and essential medical devices due to the capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.

To safeguard an effective regulatory framework for medical devices, the currently applicable rules will continue to guarantee the protection of public health, while the entry into application of the new EU rules on medical devices can be delay, in order to let medical industry to pour all their energies in increasing availability of vitally important devices.

ECM Ente Certificazione Macchine, which is proceeding with the accreditation process as Notified Body for MDR 2017/745 and plans to complete the necessary procedures within the scheduled deadlines, continues its conformity verification activity in accordance with Directive 93/42/EEC, fully committed to provide the market with the essential services to face the current crisis due to the coronavirus outbreak.

See the EC official communication >>
See the full EC proposal >> link here