The European Commission (EC) has asked EU law makers to delay the implementation of the incoming Medical Device Regulation (MDR), which is due to apply from 26 May 2020.
The proposal follows calls from the medical technology industry to pause MDR implementation to facilitate the fight against COVID-19 and to safeguard healthcare systems. The industry is currently working inexorably to provide personal protective equipment (PPE), respiratory devices and other critical medical equipment to hospitals on the frontline of the fight against the pandemic.
Fewer resources are available to ensure implementation of the key features of the new regulations, such as approval of clinical studies, and designation and auditing of notified bodies. This will “severely disrupt healthcare stakeholders’ efforts to implement the new Medical Devices Regulation (MDR) within the fixed transition timeline, which expires on 26 May 2020.”
“Whilst the new Medical Devices Regulation is key to ensure patient safety and increase transparency on medical devices across the EU, the currently applicable rules will continue to guarantee the protection of public health.”
If approved, the delay will come as a relief to device manufacturers.
It must be noted that the proposal does not include a change of date to the corrigendum published by the EC in December. The corrigendum allows upclassified class I devices to be placed on the market until May 2024, as long as a declaration of conformity has been signed before 26 May 2020. This May 2020 date has not been changed to May 2021, which would mean, if uncorrected, that declarations of conformity signed between May 2020 and May 2021 would not be valid under the corrigendum, hence, these devices can not be placed on the market under Article 120 (3) MDR, after May 2021.
The Commission has submitted this proposal in early April, for the Parliament and the Council to adopt quickly as the date of application is nearing. Our regulatory affairs consultancy experts advise that device manufacturers should continue to plan for the original dates as the proposal is only in consultation at the moment. Keep up to date with the latest information on this and other COVID-19 related stories on the Regulis news page.