The Medical Devices Introductory Course 2020

Assessing the need for PMCF (2)

• Likely to involve the same individuals or team as those conducting the clinical evaluation • Other experts should be consulted, if necessary • An iterative process and needs to be re-visited as part of clinical evaluation • During CE-marking and throughout the overall lifecycle of the device • Both the MDR and MEDDEV 2.12/2 provide a list of aspects to consider

The Organisation for Professionals in Regulatory Affairs

Examples of circumstances that may justify PMCF (1)

- Innovation , e.g., Where the design of the device, the materials, substances, the principles of operation, the technology or the medical indications are novel - Significant changes to the products or to its intended use for which pre- market clinical evaluation and re- certification has been completed - High product related risk e.g. based on design, materials, components, invasiveness, clinical procedures

- High risk anatomical locations - High risk target populations e.g. Paediatrics, elderly - Severity of disease/treatment challenges - Questions of ability to generalise clinical investigation results - Unanswered questions of long- term safety and performance

MEDDEV 2.12/2

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