This week FAQ video is about the clinical requirements under the MDR.
Would you like to know more about the differences between clinical evaluation and clinical investigation? Have a look at the article I wrote about this.
Good morning everyone,
From my camper at my holiday, I would like to give you some more information regarding the clinical requirements set out in the MDR.
The new Regulation reinforces the requirements for clinical evaluation, introducing some of the biggest changes compared to the previous regime.
As under the Directives, it includes the collection of clinical data already available in the literature as well as the setting up of any necessary clinical investigations.
The concept of equivalence with other devices for which clinical data already exists can still be used, but only in a limited number of situations, and the new rules are tighter.
The MDR set out the new and more precise requirements for clinical investigations. With only certain exceptions, implantable and Class III medical devices must now go through clinical investigations.