- The European Medical Devices Regulation (MDR) will tie post-market clinical follow-up (PMCF) data more closely to post-market surveillance and clinical evaluation report requirements.
- Medical device companies’ PMCF studies will have to include specific components identified in the MDR.
- Approvals for PMCF studies will need to be obtained by Ethics Committees and, in some cases, Competent Authorities.
Requirements for manufacturers to provide clinical data obtained via post-market clinical follow-up (PMCF) are set to both increase and intensify under the European Medical Devices Regulation (MDR), necessitating additional planning by companies planning to certify or gain re-certification under the new Regulation.
In the new European regulatory context, PMCF is required in conjunction with post-market surveillance (PMS, see Annex III) and clinical evaluation reporting (CER) obligations, as well as with risk assessments and reassessments. PMCF studies previously addressed under MEDDEV 2.12-2 guidance are now included in the MDR and the need to conduct PMCF is furthermore reinforced and expanded upon in the MDR. Article XIV, part B of the Regulation defines PMCF as “…a systematic approach to obtain additional information on the performance and safety of a medical device…” that has already obtained CE Marking when used in clinical settings. Manufacturers should develop PMCF plans including all PMCF activities for the expected lifecycle of their devices. Article XIV Part B section 6.2 of the MDR lays out specific components manufacturers should include in the PMCF plan…