The European Parliament voted today to postpone implementation of its new Medical Device Regulation (MDR) by one year, giving medtech companies a welcome reprieve from their scramble to comply.
EU MDR, originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021, if individual member states approve.
Pressure to postpone implementation of MDR has been mounting as countries around the world reel from the impact of COVID-19. In March, the trade association MedTech Europe called on EU institutions to postpone the implementation of the new MDR and in vitro diagnostics regulation (IVDR) because of the pandemic. Individual members of the European Parliament had been doing the same.
The coming implementation of MDR has already faced a slew of obstacles, with reports in September 2019 suggesting that only about a fourth of medical device companies plan to be fully compliant with the new regulations come May. In November 2019, MedTech Europe accused government authorities of dragging their feet on the process, claiming the industry was held back by the slow implementation of the new framework.
Today’s near-unanimous parliamentary vote came at the request earlier this month of the European Commission, which wanted to grant EU member governments and the medtech industry time to deal with the coronavirus pandemic.
“Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the Medical Devices Regulation from May this year,” the parliament said in a news release. “The European Parliament is therefore supporting the proposal to postpone the application of this regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.”
EU IVDR is still scheduled to go into force on May 26, 2022, a date that MedTech Europe said it continues to working to delay.