Module 15 2022

19/05/2022

When are PMCF investigations required?

• Annex III, 1(b), Indent 10 requires: • a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable • However, there is an expectation that general methods as well as specific methods will be considered when drawing up the PMCF plan • General methods include literature searches and vigilance data base searches related to the actual device, equivalent device and similar devices • Specific methods include PMCF investigations • General methods will always be required, therefore a PMCF plan will always be required • Specific methods will be determined on a case-by-case basis • If a PMCF investigation is not required a justification should be provided

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

21

When is a PMCF investigation required?

• MEDDEV 2.12/2 provides a list of reasons why PMCF investigation may be required: • Novel device (design, materials intended use, indications etc.) • Significant changes to the device or its intended use • High risk device or target population • Unanswered questions regarding long-term benefit and safety • Identification of unstudied treatment populations • Data required to validate the lifetime of the device that could not be reasonably gathered pre-market • New/emerging risks identified • When CE marking was based on equivalence

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

22

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