PMD37 EVOLUTION OF UNION EUROPEAN MEDICAL DEVICE REGULATION: PERSPECTIVE WITH THE CLINICAL EVALUATION OF DUAL MOBILITY ACETABULAR CUPS BY THE FRENCH NATIONAL HEALTH TECHNOLOGY ASSESSMENT AGENCY

Abstract

The European Union Medical Device Regulation (EU MDR) 2017/745, which appeared in 2017 and will come into force in May 2020, introduces many developments in the clinical evaluation of implantable medical devices (IMDs). In France, for years, the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) has conducted a clinical assessment of each dual mobility cup (DMC) to allow their reimbursement under a commercial name. The aim of this study was to highlight regulatory changes brought by the new regulation as suggested by the assessment of DMCs by the CNEDiMTS. A retrospective analysis of the clinical data described in the opinions issued by the CNEDiMTS was carried out from the beginning of the individual evaluation of DMCs in 2014 until the first quarter of 2019. These data were compared with the clinical requirements of the EU MDR. The CNEDiMTS supported the reimbursement of 42/71 DMCs (59%), 38 of them were based on specific clinical studies, all of which were observational. Of this 38 DMCs, 53% reported published and retrospective studies, 79% were cohorts, 71% multicentre, 74% non-comparative and the median follow-up time for patients was 40 months (mean: 45 ± 30 months). Four files of DMCs didn’t include specific clinical studies. Instead, two included a technical equivalence rationale comparing them to other DMCs. The CNEDiMTS has requested the implementation of a post-registration follow-up study for all DMCs eligible for reimbursement to confirm their in preventing dislocations and long-term survival. The CNEDiMTS formulated requirements on the specific clinical data expected. This assessment suggests that the EU MDR might require clinical studies for IMDs, with a significant restriction for equivalence. Real life monitoring studies could be designed to meet both the requirements of CE marking under the EU MDR and those of post-registration monitoring studies required for reimbursement.