Module 15 2022

20/05/2022

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 a rationale why a investigation was not conducted. ● Expected full documentation in compliance with ISO 14155:2020 (not MDR harmonised – state of the art) and to provide this.

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

14

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