Module 15 2022

20/05/2022

CEAR - CEP

Points to note: ● CEP is under more scrutiny under MDR. – Annex XIV, Part A 1a Specific points: – Clinical benefits to patients with relevant and specified clinical outcome parameters – Clinical performance and safety endpoints and acceptance criteria.

– The plan should describe the methods used to gather clinical data to support these end points.

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

9

CEAR – Equivalence

Points to note: ● CER needs to be clear on source of clinical data. – Clear statement if equivalency is used or not . Specific points: – Clearly identify equivalent device, and basic UDI-DI, if possible. – Ensure the clinical data meets MDR definition – peer reviewed, published article. – Equivalence as per Annex XIV, Sec 3. Tabulate and justify differences in terms of clinical impact.

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

10

5