The MDR, replaces the Medical Devices Directive (93/42/EEC) As the name suggests, is it a regulation and no longer a directive and all medical device companies that sell medical products in Europe have to adhere to this new regulation. Depending on your role as economic operator (manufacturer, importer, authorized representative, distributor) the impact can be meaningful. This is a massive change and will greatly increas… [1][2][3] Originally approved medical devices will have a transition time of three years[4][5] (until 26 May 2021) to meet new requirements. DEKRA has two Notified Bodies for the EU Medical Device Regulation (2017/745, MDR): DEKRA Certification GmbH (NB 0124) and DEKRA Certification B.V. (NB 0344). To do so, it introduces several key improvements, among them: 1. stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level 2. the reinforcement of the criteria for designation and processes for oversight of Notified bodies 3. the in… The steps below will guide you through the main topics. Shaded provisions are not in force. If you need help determining the regulatory requirements for your medical device in Europe, you may be interested in our custom regulatory strategy reports for Europe. Regulation 2017/745 on Medical Devices (MDR) and Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) were agreed at a political level between the three relevant European institutions (the European … Performing internal audits and a final mock audit to ensure the key requirements have been implemented. 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices (hereinafter, the "MDR") repealing Directive 90/385/EEC (hereinafter, the "AIMDD") and Directive 93/42/EEC (hereinafter, the "MDD"), entered into force on 25 May 2017. 4.3 Risk management according to ISO 14971: Your risk management activities (plan, analysis, and report) should be aligned with your PMS and PMCF activities. In May 2021, the European Medical Devices Regulation 2017… A medical device can only be sold in Europe with a CE Mark. European Medical Devices Regulation (MDR), was published in the Official Journal of the European Union on May 5, 2017. The regulation was published on 5 May 2017 and came into force on 25 May 2017. In our MDR tool you have the opportunity to search for these keywords. Regulatory Globe GmbH  Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. Manufacturers of medical devices are facing new requirements with MDR 2017/745, which took effect May 25, 2017 The Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017… The European medical device industry will undergo significant changes as a result of the new medical device regulation which has signed on May 26th, 2017. Previous Versions. With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR. The word “Declaration of Conformity” is written 38 times on the EU MDR 2017/745. 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