The coronavirus pandemic presents all of us with unprecedented challenges.
Over the next few weeks and months, the top priority for medical device companies must be producing the necessary products for medical care of the population in sufficient numbers in the coronavirus pandemic. The EC has therefore decided to postpone the application date of EU MDR to 26 May 2021. As soon as the European Council and Parliament agree, the proposal will take effect.
We are very much in favor of this measure, as medical device companies are currently unable to prepare for the EU MDR while they are doing their utmost in fighting this global crisis.
However, we recommend to not discard all EU MDR projects, but to use the extra time to continue after the pandemic has been stemmed.
Stay healthy and confident!