Nicolas Martelli1,2, Déborah Eskenazy3, Carole Déan4, Judith Pineau5, Patrice Prognon5, Gilles Chatellier6, Marc Sapoval4,7,8, Olivier Pellerin4,7,8. 1. Pharmacy Department, Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges Pompidou, 20, rue Leblanc, 75015, Paris, France. nicolas.martelli@aphp.fr. 2. University of Paris-Sud, Université Paris-Saclay, EA7358 GRADES, 5 rue Jean-Baptiste Clément, 92290, Châtenay-Malabry, France. nicolas.martelli@aphp.fr. 3. University of Paris-Sud, Université Paris-Saclay, EA7358 GRADES, 5 rue Jean-Baptiste Clément, 92290, Châtenay-Malabry, France. 4. Vascular and Oncological Interventional Radiology Department Assistance Publique - Hôpitaux de Paris,, Hôpital Européen Georges Pompidou, 20, rue Leblanc, 75015, Paris, France. 5. Pharmacy Department, Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges Pompidou, 20, rue Leblanc, 75015, Paris, France. 6. Clinical of Research Unit (URC), Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges Pompidou, 20, rue Leblanc, 75015, Paris, France. 7. Faculté de Médecine, Université Paris Descartes - Sorbonne - Paris - Cité, Paris, France. 8. INSERM U970, Paris, France.
Abstract
INTRODUCTION: The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice. MATERIALS AND METHODS: In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical investigations. RESULTS: This regulation significantly tightens controls to ensure that devices are safe and effective. In addition, equivalence to already existing devices, which allowed an accelerated access to the market, will now be possible only in some cases. Furthermore, post-marketing clinical follow-up is extended under the MDR and is required for all devices. These new requirements will probably lead to a dramatic increase in the number of clinical investigations and also to a delay in the availability of certain devices on the market. CONCLUSIONS: In the coming years, interventional radiologists are likely to be affected by these changes in their daily practice, in terms of medical device availability and/or in terms of increased involvement in clinical investigations.
INTRODUCTION: The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice. MATERIALS AND METHODS: In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical investigations. RESULTS: This regulation significantly tightens controls to ensure that devices are safe and effective. In addition, equivalence to already existing devices, which allowed an accelerated access to the market, will now be possible only in some cases. Furthermore, post-marketing clinical follow-up is extended under the MDR and is required for all devices. These new requirements will probably lead to a dramatic increase in the number of clinical investigations and also to a delay in the availability of certain devices on the market. CONCLUSIONS: In the coming years, interventional radiologists are likely to be affected by these changes in their daily practice, in terms of medical device availability and/or in terms of increased involvement in clinical investigations.
Keywords:
CE mark; Clinical investigation; Medical device; Regulation
Authors: Charlotte Koldeweij; Jonathan Clarke; Joppe Nijman; Calandra Feather; Saskia N de Wildt; Nicholas Appelbaum Journal: J Med Internet Res Date: 2021-12-13 Impact factor: 5.428