EC Publishes proposal to delay effective date of Medical Device Regulation 2017/745
Following the European Commission's March press release on the suggested postponement of the effective date of the Medical Device Regulation (the MDR), given the impact of the coronavirus pandemic, it's formal Proposal was published on Friday 3 April. This Preparatory Act, which amends the date of application of various provisions in the MDR from 26 May 2020 to 26 May 2021, has still to be approved by both the European Parliament and the Council. However, it is due to go through an expedited process to ensure that it becomes law before the 26 May deadline. We do not anticipate that objections will be raised during this process, given the need to ensure that resources are appropriately targeted during this time. Assuming that it is passed, the new Regulation will enter into force on the day it is published in the Official Journal of the European Union.
The explanatory note and accompanying press release are at great pains to ensure that the reasons behind the decision are clear – which given that manufactures have been working hard to ensure that they met the new requirements is perhaps not surprising, especially given that some Notified Bodies had ceased to accept applications under the existing Medical Device Directive (the MDD) during the latter part of 2019.
The documents explain that due to the unprecedented and completely unanticipated circumstances and public health crisis created by COVID-19, causing a significant challenge for national authorities, health institutions, members of the public and economic operators, and which requires substantial additional resources, and increased urgent availability of vitally important medical devices, the postponement of the application of many of the MDR's provisions for one year is required. As a result, the provisions of the MDD also need to be retained to continue the high level of regulatory protection, and its repeal is therefore similarly delayed. The Proposal therefore includes an amendment the transitional provisions contained in Article 120 and the repeal provisions in Article 122, as well as amendments to the effective date contained in the various Articles.
In addition, the Proposal also amends Article 59 of the MDR so that it applies from the date of entry into force of this Regulation until 25 May 2021. Article 59 enables competent authorities in a member state to authorise the placing on the market or use of devices which have not gone through the required conformity assessment process where this is justified by the circumstances. This reflects the use of steps already taken by, for example, the UK authority, the MHRA under existing provisions in the MDR. The amendment also enables the EC to adopt EU-wide derogations to reflect these national measures. This is designed to ensure that potential shortages of critical medical devices, such as ventilators, can be dealt with effectively, at both a national and EU-wide level.
As set out above, we do not anticipate that objections will force this Proposal off-course, although we suspect many manufacturers will be slightly irked by this decision, given the closeness of the timing to the effective date of the MDR. We therefore expect the Regulation to be published in the Official Journal just prior to 26 May.