OBJECTIVES: The EU Medical Device Regulation 2017/745 (MDR) requires rigorous clinical evidence for market approval particularly for high-risk devices and continuous post-market surveillance plan. This applies for Post-Market Clinical Follow-up (PMCF) studies, which reinforce clinical trial evidence through real-world data. For high-risk and custom-made devices (CMDs) that are highly personalized technologies, often with limited evidence available, collecting real-world long-term outcomes becomes significant.

The aim of this abstract is to report the methodological framework for a unique PMCF study on medical devices compliant with MDR.

METHODS: Currently, two class III Thoracic Stent Graft systems by a Company are available on the market for: one is a standard device, whereas the other one is a CMD. The notified body (NB) requested both long-term and short-term safety information for the standard device and for the CMD, respectively.

The proposed framework to design a PMCF study protocol for a cardiovascular implantable CMD is based on: (1) in-depth study of regulations and guidance documents (MDR and Medical Device Coordination Group Guidelines); (2) analysis of existing literature; (3) application of UNI-EN-ISO 14155:2020 and (4) expert clinician validation.

RESULTS: To respond to the Notify Body’s (NB) request an observational retrospective and prospective cohort PMCF study protocol was designed, aimed to enroll two cohorts in 30 sites located in Italy, 80 patients to be followed for 5 years with a standard device and 50 patients to be followed for 1 year with a CMD. Both cohorts will describe clinical outcomes in terms of performance and safety.

CONCLUSIONS: The proposed framework in compliance with the MDR allows to outline a rigorous PMCF study for class III medical device, providing significant information requested by NBs. Since each CMD is unique, high-quality evidence coming from routine clinical practice is extremely valuable to contribute to patients’ safety and improve technology safe innovation.