Module 15 Presentations

10/04/2024

Introducing MDCG 2020-13: CEAR Template

Why should a manufacturer read a Notified Body Guidance document? To ensure their CER provides this information. If the CER cannot address all points then there is a deficiency to correct.

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

7

CEAR

Points to note: ● Include SRN & Basic UDI-DI in the CER. ● CVs for authors are required. ● Authors are expected to have expertise that includes knowledge of clinical diagnosis and management of conditions.

Module 15 Lecture 4

The Organisation for Professionals in Regulatory Affairs

8