contact@lne-america.com 1-301-495-0477 lne-america.com LNE/G-MED North America, Inc MDR Common changes, Timeline for changes and the Impact on manufacturers. 4/28/2017 Do not distribute or reproduce without permission 1
contact@lne-america.com 1-301-495-0477 lne-america.com Speaker 4/28/2017 Do not distribute or reproduce without permission 2
contact@lne-america.com 1-301-495-0477 lne-america.com Agenda • Introduction • Origin of MDR • Goal of MDR • Summary of the main changes in the regulation • Expected timeline for the changes to be implemented • How manufacturers can prepare • Tips and conclusion 4/28/2017 Do not distribute or reproduce without permission 3
contact@lne-america.com 1-301-495-0477 lne-america.com Introduction 4/28/2017 Do not distribute or reproduce without permission 4
contact@lne-america.com 1-301-495-0477 lne-america.com Origin of MDR The MDR proposal started back in 2008 when the EU commission triggered a consultation on the community’s existing requirements covering medical devices. 4/28/2017 Do not distribute or reproduce without permission 5
contact@lne-america.com 1-301-495-0477 lne-america.com Origin of MDR The plan was 1 st released by the commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing : EU’s current medical device directive (93/42/EEC) EU’s directive on active implantable medical device (90/385/EEC) In Vitro Diagnostic directive (98/79/EC) 4/28/2017 Do not distribute or reproduce without permission 6
contact@lne-america.com 1-301-495-0477 lne-america.com Goal of MDR 4/28/2017 Do not distribute or reproduce without permission 7
contact@lne-america.com 1-301-495-0477 lne-america.com Goal of MDR This regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small-and medium-sized enterprises that are active in this sector. 4/28/2017 Do not distribute or reproduce without permission 8
contact@lne-america.com 1-301-495-0477 lne-america.com Goal of MDR This regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products . 4/28/2017 Do not distribute or reproduce without permission 9
contact@lne-america.com 1-301-495-0477 lne-america.com Goal of MDR Conformity Supervision Clinical Vigilance and of notified assessment investigations & market procedures bodies evaluation surveillance 4/28/2017 Do not distribute or reproduce without permission 10
contact@lne-america.com 1-301-495-0477 lne-america.com Summary of main changes in the regulation 4/28/2017 Do not distribute or reproduce without permission 11
contact@lne-america.com 1-301-495-0477 lne-america.com Summary of main changes in the regulation 1. Wider, clearer scope of the products covered: The scope of the products will become broader to include: Medical devices which may not have the intended medical purpose Devices for the purpose of prognosis of the a disease or any other health condition 4/28/2017 Do not distribute or reproduce without permission 12
contact@lne-america.com 1-301-495-0477 lne-america.com Summary of main changes in the regulation 2. Changes in the clinical investigation for medical devices as part of the requirements of the clinical evaluation: The MDR will put in place a European regimen for clinical investigations that will replace the diversity of member state regulation in the EU. It will introduce many new concepts relating to clinical evaluation and clinical investigation, as well as a mandatory PMCF and Periodic Safety Update Reports (PSURs). 4/28/2017 Do not distribute or reproduce without permission 13
contact@lne-america.com 1-301-495-0477 lne-america.com 2. Changes in the clinical investigation for medical devices as part of the requirements of the clinical evaluation: Summary of main changes in the regulation PSUR class IIa class IIb Devices class III 4/28/2017 Do not distribute or reproduce without permission 14
contact@lne-america.com 1-301-495-0477 lne-america.com 2. Changes in the clinical investigation for medical devices as part of the requirements of the clinical evaluation: Summary of main changes in the regulation PSUR shall set out: The conclusions of the benefit-risk determination The main findings of the PMCF The volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device. 4/28/2017 Do not distribute or reproduce without permission 15
contact@lne-america.com 1-301-495-0477 lne-america.com 2. Changes in the clinical investigation for medical devices as part of the requirements of the clinical evaluation: Summary of main changes in the regulation PSUR Update Class IIb and III Class IIa Years 2 1 4/28/2017 Do not distribute or reproduce without permission 16
contact@lne-america.com 1-301-495-0477 lne-america.com 2. Changes in the clinical investigation for medical devices as part of the requirements of the clinical evaluation: Summary of main changes in the regulation The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system up on request. 4/28/2017 Do not distribute or reproduce without permission 17
contact@lne-america.com 1-301-495-0477 lne-america.com 2. Changes in the clinical investigation for medical devices as part of the requirements of the clinical evaluation: Summary of main changes in the regulation Please note that with the new rules; the manufacturers will need to perform: Gap analysis to identify gaps in clinical evidence under new rules for devices currently on the market and perform the required update since the compliance to current MEDDEV’s without an update to the clinical strategy and performing the gap analysis will not be sufficient. 4/28/2017 Do not distribute or reproduce without permission 18
contact@lne-america.com 1-301-495-0477 lne-america.com 2. Changes in the clinical investigation for medical devices as part of the requirements of the clinical evaluation: Summary of main changes in the regulation This will require: A thorough review of the manufacturer’s clinical strategy and PMCF plans. Manufacturers to conduct clinical performance along with providing evidence of safety and performance in accordance to the risk associated with the device Collect post – market clinical data. 4/28/2017 Do not distribute or reproduce without permission 19
contact@lne-america.com 1-301-495-0477 lne-america.com Summary of main changes in the regulation 3. Unique device identification (UDI): In order to improve the ability of the authorities and manufacturer to trace the specific devices through the supply chain and to smooth the recall process of medical devices that have been found to present a safety risk, the MDR mandates the use of unique device identification (UDI) mechanisms. 4/28/2017 Do not distribute or reproduce without permission 20
contact@lne-america.com 1-301-495-0477 lne-america.com 3. Unique device identification (UDI): Summary of main changes in the regulation The UDI system should apply to all devices placed on the market except custom-made devices. 4/28/2017 Do not distribute or reproduce without permission 21
contact@lne-america.com 1-301-495-0477 lne-america.com Summary of main changes in the regulation 4. Creation of European Database on Medical Devices (Eudamed). 4/28/2017 Do not distribute or reproduce without permission 22
contact@lne-america.com 1-301-495-0477 lne-america.com 4. Creation of European Database on Medical Devices (Eudamed). Summary of main changes in the regulation The purpose is to integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, clinical investigations, vigilance and market surveillance. 4/28/2017 Do not distribute or reproduce without permission 23
contact@lne-america.com 1-301-495-0477 lne-america.com 4. Creation of European Database on Medical Devices (Eudamed). Summary of main changes in the regulation The European database on medical devices (Eudamed) will: Enhance overall transparency, Provide better access to information for the public and healthcare professionals, Avoid multiple reporting requirements. 4/28/2017 Do not distribute or reproduce without permission 24
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