The Medical Devices Introductory Course 2020

Why and how PMCF is performed PLANNING AND UNDERTAKING PMCF

The Organisation for Professionals in Regulatory Affairs

Assessing the need for PMCF (1)

• Typically considered as part of the clinical evaluation process • MEDDEV 2.7/1 rev. 4 ”In order to determine needs, the evaluators should describe residual risks and any uncertainties or unanswered questions. The evaluators should also include aspects such as rare complications, uncertainties regarding medium- and long-term performance, or safety under wide-spread use” • MEDDEV 2.12/2 rev. 2, ”studies must be based on the identification of possible residual risks and/or unclarity on long term clinical performance that may impact the benefit/risk ratio” • N.B. This guidance document is old (2012) and due to be replaced

The Organisation for Professionals in Regulatory Affairs