Post-market Clinical Follow-up (PMCF) GAP Analysis for Legacy Devices Class III between the Medical Device Directive (MDD 93/42/EEC) and the Medical Device Regulation (MDR 2017/745)
| Autor: | Marina Makeenko, Thierry Chevallier |
|---|---|
| Přispěvatelé: | Biotechni SAS, Laboratoire de Biostatistique, Epidémiologie clinique, Santé Publique Innovation et Méthodologie [CHU Nîmes] (BESPIM), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), French alliance clinical trial [Paris] (F-CRIN), French-Clinical Research Infrastructure Network - F-CRIN [Paris] (Cardiovascular & Renal Clinical Trialists - CRCT ), Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Ana Roque, Ana Fred, Hugo Gamboa, KARLI, Mélanie |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | 15th International Joint Conference on Biomedical Engineering Systems and Technologies. Special Session on Dealing with the Change in European Regulations for Medical Devices 15th International Joint Conference on Biomedical Engineering Systems and Technologies. Special Session on Dealing with the Change in European Regulations for Medical Devices, Feb 2022, Vienne, Austria. pp.273-280, ⟨10.5220/0010889400003123⟩ |
| DOI: | 10.5220/0010889400003123⟩ |
| Popis: | International audience; The passage from the MDD 93/42/CEE to the MDR 2017/745 remains a big challenge for the manufactures. The interpretation of the regulatory requirements stays unclear and can differ from one source to another, especially when it comes to the clinical evaluation. Will the data collected under the MDD 93/42/CEE be sufficient to prove the safety and security of the device? Under the directive each country was establishing its own requirements for the conduct of the studies. The MDR has standardized these rules, so that all the clinical data collections follow the same pathway. We will examine the PMCF of the class III devices already CE marked under the directive (legacy devices) to find out if the new requirements will be asked to be in compliance with the MDR. A Gap analysis between the MDD and MDR will help us in our research. A matrix in the form of a questionnaire will be established to help us verify compliance of the PMCF under the MDR. |
| Databáze: | OpenAIRE |
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