EU’s Parliament Adopts MDR Delay of One Year

To prevent shortages or delays in getting key medical devices on the market, the European Parliament has decided to postpone the application of the Medical Devices Regulation. This regulation on medical devices was adopted in 2017 and was supposed to be fully applicable on May 26, 2020.
 
Parliament adopted the commission proposal on Friday, allowing the application of the Medical Devices Regulation to be postponed by one year until May 26, 2021.
 
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.
 
Therefore, the European Parliament is supporting the proposal to postpone the application of this regulation by one year to allow authorities and manufacturers alike to prioritize the fight against the coronavirus pandemic by continuing under current procedures.
 
The proposal now also 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 May 26.