In Europe, several years ago, it was decided to move from medical device directives (MDD), to European regulation (MDR).
Since May 2021, the European market has been subject to the new MDR legislation.
Back in 2017, Diasoft started preparing to qualify for this law. In 2021, we had our first MDR audit and this week we (finally) received our certificate after years of hard work. Besides the fact that the law places huge additional requirements on us as a company, it has mainly taken so long because the notified bodies that have to audit us had to be accredited for the MDR themselves first. Not all the notified bodies have managed to receive accreditation, leaving the remaining institutions terribly busy.
We are therefore very proud that we managed to get the MDR certificate!