European Commission proposes one-year postponement in light of the COVID-19 crisis.
On 25 March 2020, the European Commission announced that it was working on a proposal to postpone the date of application for the new EU Medical Devices Regulation (MDR)[i] for one year, in light of the COVID-19 crisis. The MDR had been due to become fully active on 26 May 2020.
The Commission’s Directorate-General for Health and Food Safety noted in a press release that the Commission was working to submit this proposal in early April, for swift adoption by the European Parliament and the European Council. The proposed postponement aims to relieve pressure on national authorities, notified bodies, manufacturers, and others, allowing them to focus fully on urgent COVID-19-related priorities.
The Commission’s proposed regulation was published on 3 April 2020 and is available here. While the draft regulation, for the most part, pushes back the implementation of the MDR by one year, the provisions of Article 59 will be partially amended and come into effect on the date of entry into force of the postponement regulation. Article 59 allows for national derogations from the conformity assessment requirements of the MDR or the currently applicable medical device directives where this is in the interest of public health or patient safety or health. The amended Article 59 permits the Commission to also extend, in exceptional cases, such national derogations to the entire EU for a limited period of time, including national derogations made prior to the entry into force of the postponement regulation to address potential COVID-19 related shortages.
The announcement follows calls for postponement from trade associations, including MedTech Europe, who have also called for implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR)[ii] to be delayed. The IVDR is currently due to come into force on 26 May 2022, but the Commission has not yet announced any plans to implement a corresponding postponement.
Separately, and unrelated to COVID-19, the Commission announced in October 2019 the postponement of the launch of Eudamed — the new database that will be used to monitor the safety and performance of devices under the MDR and IVDR. Eudamed is now anticipated to be operational in May 2022 to coincide with the implementation of the IVDR. However, as noted above, it remains to be seen whether this date could be further postponed.
How the UK will react to this proposal remains to be seen. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 mirror the MDR in UK domestic legislation, with necessary amendments (the UK MDR). The UK MDR is due to be effective from 31 December 2020. As it stands, if the Commission’s proposal is passed, the UK MDR will come into effect prior to the MDR.
The MDR and IVDR aim to increase harmonisation across the EU with respect to medical devices and in vitro diagnostic devices and to address weaknesses in the current regimes, with the goal of increasing protection for consumers. Once effective, the two regulations will introduce wide-ranging changes that will affect all aspects of the supply chain and life cycle for medical devices and in vitro diagnostic devices. Latham & Watkins examined the changes the MDR and IVDR will introduce in this May 2019 Client Alert.
Latham & Watkins will continue to monitor and report on developments related to the MDR and IVDR.
This post was prepared with the assistance of Leanne Chen in the London office of Latham & Watkins.
[i] Regulation (EU) 2017/745
[ii] Regulation (EU) 2017/746