Module 15 Presentations

10/04/2024

CEAR –Methodology

Points to note: ● Search covers all variants and accessories, all indications. ● Separate searches provided for SOTA and clinical data on device. Provide methodology for both. ● Provide along with CER: – Literature search protocol and reports (if incorporated within the CEP/CER state this) – Full list of all articles identified by the search – Full list of the excluded articles, with reasons for exclusion. – Full text copies of all articles included in the CER.

– Provide this at MDR submission – or it will be requested. Also include anytime the NB needs to review the CER (e.g. renewal).

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

13

CEAR –Clinical Investigation

Points to note: ● Especially for class III and implantables there needs to be a rationale if an investigation was not conducted. ● Clinical investigation is expected to be compliant with ISO 14155:2020 (not currently MDR harmonised but is considered state of the art) ● The submission should include documentation to demonstrate this compliance: – CIP/CIR – Ethics approval – Regulatory authority approval – Transferability justification for studies conducted outside EU – Gap analysis if standard applied is not 14155

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

14