Post market clinical follow-up (PMCF)

Under the Medical Device Directives (MDD), Post market clinical follow-up (PMCF) is mentioned only three times, twice in Annex II EC Declaration of Conformity (Full quality assurance system), section 5 Surveillance, and once in Annex X Clinical Evaluation, section 1 General provisions. The MDD does not define PMCF, only states that it is part of the post-market surveillance, and where it is not deemed necessary, this must be “duly justified and documented”.
The details relevant to PMCF are found in MEDDEV 2.7/1 Guidelines for clinical evaluation, the latest version being revision 4 of June 2016. The MEDDEV guideline includes definitions for PMCF plan and PMCF study. They also clarify that PMCF studies are systematic, and typically include estimation of residual risks and uncertainties or unanswered questions, such as rare complications, uncertainties regarding long-term performance, safety under wide-spread use.