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?