As expected, the European Parliament has voted in favour of postponing the date of application (DoA) of EU-MDR for one year (i.e. entry into force in May 2021). However, the legislative/bureaucratic procedure for the finalization of the amendment is still ongoing.
If you want to know more on the next steps, read here: The next steps for MDR DoA extension
When the amendment is official & public, we will be in a position to discuss the specific transitional provisions (Art.120).
Nevertheless, amid COVID19 pandemic and given that DoA of IVDR remains unchanged and EUDAMED is still expected to go live in May 2022, this is a moment of relief but not relaxation.
Evnia advises Manufacturers to not put a halt to the vigorous execution of their regulatory strategies on the grounds of the postponement. This extension can only be of service if Manufacturers treat it as a chance to accelerate their RAQA activities.
