Module 15 2022

20/05/2022

MDR Requirements relating to CEAR

Scrutiny Procedure (Article 54 (3) / Annex IX, Sec 5.1) • Class III implantable and Class IIb active devices intended to administer and/or remove a medicinal product (rule 12). • The CEAR is transmitted along with the manufacturer’s clinical evaluation documentation to the Commission. • The Commission will forward the CEAR and clinical documentation to the expert panel. • The expert panel has 21 days to decide if it will provide a scientific opinion or not. • At Day 21 the expert panel needs to inform the Notified Body if it is not providing an opinion. • If a scientific opinion on the CEAR is to be provided – 60 day deadline. • The Notified Body shall consider the decision of the expert panel. • Final decision for certification is the Notified Bodies.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 4

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Guidance Document relating to CEAR

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 4

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