Commission delays MDR by 12 months

26.03.2020

Following a call from MedTech Europe to postpone the implementation of the Medical Device Regulation (MDR)[1] and In Vitro Diagnostic Regulation (IVDR)[2] (together, the Regulations) in response to the COVID-19 crisis, the European Commission made the following announcement yesterday:[3]

Today (25 March 2020), the Commission announced that work on a proposal to postpone the date of application for the Medical Device Regulation (MDR) for one year is ongoing. The decision was reached with patient health and safety as a guiding principle.

The Commission is working to submit this proposal in early April for the Parliament and the Council to adopt it quickly as the date of application is the end of May. This decision will relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them to fully focus on urgent priorities related to the coronavirus crisis.

The  MDR was due to take effect on 26 May 2020 (the Date of Application). We have written about the challenges posed by this deadline extensively in previous On The Pulse articles.[4] These changes represent a significant administrative burden for manufacturers, especially as very few notified bodies (only 12 as of today) have gone through the process of re-certification under the MDR, limiting capacity for devices to be re-certified under the new legislation. Moreover, the provisions the IVDR will bring in when it comes into full force on 26 May 2022 are no less onerous and time-consuming to comply with.

The disruption brought by the COVID-19 pandemic has created a further, possibly insurmountable hurdle to meeting the deadline for MDR compliance, and represents a serious setback for IVDR preparedness. At the same time as businesses and notified bodies have been forced to close their doors and work from home where possible, the need for medical devices to be brought swiftly and seamlessly to market gone up. In that context, the Commission’s announcement is no surprise.

Manufacturers should not take this announcement as a green light to sit back and take their focus off the Regulations. For one, the Commission’s announcement makes it abundantly clear that the proposal is still being worked up. No indication has yet been given of the content of the proposal – the Date of Application may be postponed by a year, but we do not know:

  • Whether the other dates in the MDR, such as the transitional periods for up-classified Class I medical devices, will also be pushed back a year;
  • What the status of the old regulatory framework, the Medical Device Directive[5] and the Active Implantable Medical Device Directive[6], will be if the Date of Application is postponed; or
  • if it will be possible to obtain medical device certification under the old legislation in the interim.

There is also no indication that the Commission intends to change the timeline for implementation of the IVDR, so work on that still needs to continue apace.

Second, there is no guarantee that postponing the Date of Application will avoid the anticipated exit of Switzerland and Turkey from the EU regulatory framework. Postponement will give them more time to implement the MDR and negotiate new mutual recognition agreements with the EU of the sort that allowed them to participate in the old framework, but it will not solve the underlying political issues that led to their expected exit from the EU framework in the first place. Postponement will also have no effect on the Brexit timeline, so unless a deal is struck the UK will become a third country to the EU Regulations on 1 January 2021.

Third, the Commission’s proposal will still need to be implemented through the EU legislative process. As a result, Member States will be able to propose amendments if they wish, which will either delay the passage of the new legislation or result in it doing things the Commission didn’t intend. Given the Covid-19 situation, the EU legislature may wish to simply rubber-stamp the Commission’s proposal as fast as possible in order to avoid being obstructive, but the possibility for them to do more is there and so nothing should be taken for granted.

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[1] Regulation 2017/745

[2] Regulation 2017/746

[3] https://ec.europa.eu/health/sites/health/files/docs/20200325_news_md_en.pdf

[4] Found here, here, here and here.

[5] 93/42/EEC

[6] 90/385/EEC

Jack Hostick

Author

Jamie Hatzel - Trainee Solicitor

Jamie Hatzel

Author