"Appropriateness" of Clinical Data Under Regulation (EU) 2017/745- A Case Study and Survey.

Purpose: Regulation (EU) 2017/745, the European Medical Device Regulation (MDR), raises clinical evidence requirements but lacks clarity on what constitutes "sufficient clinical evidence" for medium-risk, Class IIb non-implantable CE-marked devices. This research investigates whether a clinical evaluation of a newly developed Class IIb device can be conducted without a clinical investigation and explores the role of data from the same generic device group in clinical evaluations.

Methods: Expert interviews with notified body reviewers and a survey were conducted to assess the regulatory landscape and the appropriateness of non-clinical data.

Results: Findings reveal inconsistencies in the interpretation of MDR among notified bodies. While some reviewers accepted clinical evaluations based on non-clinical data, others required clinical or equivalent device data. The exclusion of data from the same generic device group under MDR complicates compliance and may impose unnecessary burdens on manufacturers, particularly for standard-of-care devices with well-documented safety profiles. Survey results indicate discrepancies in the role of non-clinical data, with notified bodies favouring standard-based bench testing while manufacturers and consultants advocate for advanced testing methodologies, such as in silico models. The study also highlights differing perspectives on the role of post-market clinical follow-up (PMCF) in clinical evaluations.

Conclusions: This research underscores the need for standardized guidance on clinical data requirements and the role of non-clinical evidence. Addressing these gaps is essential to balance patient safety with innovation and streamline the regulatory pathway for medium-risk medical devices, ensuring a more predictable and efficient approval process in the EU.