Post-market clinical follow-up known as PMCF is an integral part of the clinical evaluation of CE marked medical devices. PMCF allows for continuous monitoring of devices after they have been placed on the market and ensures their continued safety and efficacy. PMCF can take different forms, including e.g. analysis of real-life clinical data, monitoring of registry data or retrospective studies or. A high-quality form of PMCF is the PMCF investigation, which is usually performed for higher risk medical devices.
You may have come across an interpretation from the State Institute for Drug Control according to which only the manufacturer of the relevant medical device could be the sponsor of a PMCF investigation, which was justified by the fact that the PMCF investigation is the responsibility of the manufacturer - if someone else was the sponsor, it would be a different clinical investigation within the meaning of article 82 of the MDR.
We could not agree with this interpretation for two reasons:
1. The term sponsor is defined in article 2 of the MDR as follows: 'sponsor (means) any individual, company, institution or organisation which takes responsibility for the initiation, management and setting up of the financing of the clinical investigation'. It is clear that the sponsor can be a much wider range of entities. The definition links the role of the sponsor to the clinical investigation, not to the PMCF investigation. However, if we look at the definition of a PMCF investigation, hidden in article 74 of the MDR, we find that a PMCF investigation is one type of clinical investigation. Nowhere in its requirements for PMCF investigations does the MDR specify a limitation on the role of the sponsor.
2. The factor that determines the choice of the correct regulatory procedure under article 74 (PMCF investigation) or article 82 (other clinical investigation) is the objective of the trial, not which entity acts as sponsor. If the investigation is carried out within the intended purpose of a device bearing the CE marking, it is a PMCF investigation. If it is conducted for a different purpose, it is a different clinical investigation.
The SIDC revised its original position and now allows PMCF investigations to be performed by other sponsors. This change brings significant flexibility to the regulatory framework and facilitates the conduct of PMCF investigations, which is slowly becoming common practice, particularly for higher risk devices.
Author: Lýdie Hojková