The European Parliament has voted to postpone the enforcement of European Medical Devices Regulation (EU MDR) to allow companies to focus on fighting Covid-19.
EU MDR applies to all manufacturers selling medical devices within Europe and aims to provide greater protection of public health and safety.
The legislation will now come in to force on 26th May 2021. This is a year later than originally planned.
The European Commission’s proposal was accepted by Parliament on Friday 17th April, with an overwhelming majority of 693 votes to one, and two abstentions.
By delaying this legislation, the European Parliament is allowing medtech companies and manufacturers to prioritise coping with the coronavirus pandemic over the next few months.
This news will likely be welcomed by manufacturers, who according to a survey by software company Climedo Health earlier this year, were not ready for this legislation. The survey reported the following key findings:
- Only 26% had a fully MDR-compliant QMS.
- 34% did not yet have a notified body or were currently switching notified bodies.
- Almost half did not (yet) have a PMS plan.
- Many companies still used paper (48%) and/or Excel spreadsheets (69%) for clinical data collection (multiple selections possible).
Additionally, at the beginning of this year, Peter Rose, managing director - Europe at Maetrics, a life sciences consultancy firm, told Medical Plastics News: “Industry is increasingly becoming concerned about the timetable for the EU MDR. Three year transition periods are well established in our industry, but never have I seen a transition period being used to get the system ready.”
Scott Whittaker, president and CEO, AdvaMed also previously expressed his concern with the 2020 deadline: “Industry is concerned that while we are prepared, key elements of the new EU regulatory system will not be ready sufficiently ahead of these deadlines to enable industry to comply with the new rules in time.”
Following this vote, the proposal now has to be approved by the member states and published in the Official Journal before it will enter into force. This is expected at the latest by 26th May this year.