Amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions

Reasons for and objectives of the proposal Regulation (EU) 2017/745 of the European Parliament and of the Council, adopted on 5 April 2017, establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and
users, and taking into account the small- and medium-sized enterprises that are active in this sector.

The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens and economic operators. The COVID-19 crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745.

Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745 and therefore it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.
In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745 by one year. At the same time, it is necessary to defer the date of repeal of Directives 90/385/EEC and 93/42/EEC.

Those deferrals safeguard the presence of a functioning regulatory framework on medical devices from 26 May 2020. In addition, the proposed amendment seeks to ensure that the Commission is able to adopt, in exceptional cases, Union-wide derogations in response to national derogations at the earliest date possible in order to address potential shortages Union wide of vitally important medical devices in an effective manner.


European Commission Proposal

Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context