Clinical requirements under the MDR

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.

 

Transcript:

 

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.

Share This Post

Share on facebook
Share on linkedin
Share on twitter
Share on email

Other articles

Clinical Investigations

Safety reporting under MDR in The Netherlands part III

In this video, the following question is briefly answered: “When does vigilance reporting apply and who is responsible for this process?”   Transcript:   In this “trilogy” we talk about the safety reporting of different legal frameworks in The Netherlands.   The last 2 weeks we talked about safety reporting for clinical investigations that are

Clinical Investigations

Safety reporting under MDR in The Netherlands part II

In this video, the following question is briefly answered: “How do clinical investigations under article 82 comply with safety reporting in The Netherlands?”   Transcript:   Last week, we began looking at safety reporting. Today, we’re going to briefly focus on the following follow-up question:   How do clinical investigations under article 82 comply with

Scroll naar top