Module 15 2022

19/05/2022

Notified Body expectations

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

29

Notified body expectations

• PMCF plan can be part of the PMS plan as long as all PMCF requirements are met • There MDCG 2020-7 and MDCG 2020-8 PMCF templates are used • There is an unwritten assumption that literature searches, a general method of PMCF will always be carried out • If PMCF investigations, a specific method of PMCF, are not carried out a justification will be provided • A PMS and PMCF plan will always be needed for each medical device • The manufacturer is responsible for submitting PSURs and ensuring they are assessed by the Notified Body

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

30

15