A vote in the European Parliament has decisively approved a delay to full implementation of the EU’s MDR by one year, allowing the medical device industry to prioritise its Covid-19 response efforts.
The EU MDR implementation date was set for 26th May 2021. However in light of this coronavirus pandemic and with an urgent need for medical device manufacturers to help supply much needed equipment to resource-stretched hospitals, a proposal crafted by the European Commission received an approval — 693 votes in favour, 1 against, and 2 abstentions — to push back the implementation date.
This delay will be welcomed by some companies that were not ready for the switch-over, and it offers more time to take stock, zoom out and re-assess their regulatory strategy. We offered 5 tips to make best use of more time that might help in such a re-evaluation.