The translation is as follows:

Recently, the European Commission has passed a proposal to postpone the application date of the Medical Device Regulation by one year, allowing member states, health institutions, and economic operators to prioritize responding to the COVID-19 pandemic. This decision takes into account the unprecedented challenges faced by the coronavirus pandemic and the increasing demand for critical medical equipment across the EU, while continuing to ensure patient health and safety until new regulations come into effect.

Margaritis Schinas, Vice President for Promoting Our European Lifestyle, said, "There is currently no choice between certification on critical medical devices or delays or delays in the market. Therefore, the European Commission is taking a pragmatic approach and delaying the application of new EU regulations to medical devices, so we can let our healthcare industry focus all its energy on what we need them to do: help fight the pandemic. This once again demonstrates that the European Union will not waver in supporting our national public health systems when needed

Our top priority is to support member states in responding to the coronavirus crisis through all necessary means and to protect public health as strongly as possible, "said Stella Kyriakides, Commissioner for Health and Food Safety." Any potential market disruption in terms of safety and availability of necessary medical equipment must be avoided. Today's decision is a necessary measure in this very special time

With the increasing demand for certain important medical devices due to the coronavirus crisis, it is crucial to avoid any other difficulties or potential shortages or delayed availability risks of such devices caused by capacity limitations of regulatory authorities or conformity assessment agencies related to the implementation of medical devices. Equipment regulations.

Therefore, due to current special reasons, this proposal has postponed the implementation of the regulations by one year until May 26, 2021.

Although the new Medical Device Regulation is key to ensuring patient safety and improving transparency of medical devices throughout the EU, the current applicable regulations will continue to ensure the protection of public health.

In addition, the proposal ensures that member states and committees can address potential shortages of critical medical equipment in the EU in a more effective manner through EU wide reductions.

Original text:

https://ec.europa.eu/commission/presscorner/detail/en/IP_20_589