The European Commission is working on a proposal to delay the implementation of the EU 2017/745 Medical Devices Regulation (MDR / the Regulation) until 2021.
This implementation which was due to take effect on 26 May 2020 requires its proposal to be submitted by April 2020.
The Commission has stressed the importance of the proposal to be submitted as soon as possible as the deadline for the regulation approaches.
This new regulation would mean a longer timeline needed for placing medical devices on the European market. They might pose potential consequences on the manufacturer’s capacity to produce necessary medical equipment such as breathing masks and protective clothing as medical devices are required to be re-assessed to ensure that they comply with the requirements.
The main objective of this deferral is to help healthcare providers overcome the COVID-19 outbreak and ensure that manufacturers will still be able to provide healthcare systems with the necessary medical devices and technologies.
The deferral would also lift pressure on healthcare stakeholders as they are now able to prioritize the most urgent needs sourced by the current crisis.