Module 16 2022

05/09/2022

Typical Non Conformities relating to PMCF

• No mention or coverage of PMCF in the PMS plan. • Incorrect interpretation of the purpose of PMCF; assumption is that if there are no clinical studies, PMCF not required. • Devices that are equivalent to currently approved products do not require PMCF. • Similar devices have been on the market for over 20 years and therefore PMCF not necessary.

The Organisation for Professionals in Regulatory Affairs

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Situation • Manufacturer has a variety of devices of varying levels of risk and uses their PMS procedure as the basis of their PMS Plan Implication • This may be sufficient to support CE marking of a device. A PMS / PMCF Plan specific to a device / group of devices is usually needed to confirm clinical performance and safety throughout the expected lifetime Not having an appropriate PMS plan or not executing an approved plan

The Organisation for Professionals in Regulatory Affairs

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