The coronavirus pandemic and the associated health crisis represent an unprecedented challenge for Member States, national authorities, health institutions and economic operators. The coronavirus crisis has created extraordinary circumstances requiring significant additional resources and increased availability of vital medical devices. None of this could have been foreseen when the Medical Devices Regulation was adopted.

 The date of application of the Medical Devices Regulation (EU) 2017/745 has been postponed by one year to allow Member States, health institutions and economic operators to give priority to the fight against COVID-19. This decision takes into account the need for increased availability of medical devices in the EU, while continuing to ensure the health and safety of patients until the new legislation enters into force.

 Weaknesses or delays in obtaining certification and marketing of major medical devices are not currently an option. The Commission is pragmatically delaying the entry into force of the new rules on medical devices. Therefore, the medical industries will be able to continue to put their energies into what is needed: contribute to fighting the pandemic.

 As the coronavirus crisis increases the demand for medical devices, it is essential to avoid difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity constraints of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.

 Today's proposal therefore postpones, for exceptional reasons, the application of the Regulation for one year - until 26 May 2021.

Notes

- Regulation (EU) 2017/745 on medical devices amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repeals Council Directives 90/385/EEC and 93/42/EEC.

- This proposal is without prejudice to the date of application of the Regulation on medical devices for in vitro diagnosis, which becomes applicable as from 26 May 2021.