Clinical Investigation under MDR

Description:

1. Developments around Clinical Investigations under MDR at EU level
Steve Eglem

- EU interpretation of the borderline between art 62 and art 82 studies (basically the very nice schedule you’ve been working on….)
- preparations for Eudamed: formats and expectations (despite the delay in Eudamed,still investing for participants to learn how the preparations are going and the main elements of the “CI module”. )
- anything else you would like to share with the audience from your work in CIE related to Clinical Investigations

2. Clinical Investigations from the perspective of a Competent Authority in the ‘transition year’
Tim De Schutter

-How has FAHPM prepared for CIs under MDR?
-What do you see happening in the field during your inspections?
-How are companies and research institutions preparing for the new MDR procedures? Do you see an increase in the number of CIs?
-Any ’trends’ you can share? Any advice for the participants?

3. Clinical investigations from the perspective of industry in the ‘transition year”
Loes Pelgrim

-What do you see happening in the field?
-How are your clients preparing?
-What trends do you see and what advice can you give participants?