Improving the safety of medical devices. Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). Regulation (EU) No. MedTech Summit 2020 | EU Medical Device Regulation, Notified Body Overview and Update from BSI BSI Medical Devices and the impact of COVID-19 on audits As the coronavirus COVID-19 outbreak evolves, the safety and wellbeing of our clients and colleagues is our highest priority, so please read our latest updates on how we are managing global audits and assessments. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). In view of the Covid-19 pandemic, the EU Commission has extended this transition period to May 25, 2021. 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. Nick Paul Taylor ... to sell their devices in the EU. The new regulatory landscape on software medical devices that will apply under the new Regulations (Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/756 (In Vitro Diagnostic Regulation (IVDR)) as of 26 May 2020 and 26 May 2022 respectively, has been somewhat clarified by new guidance published by the European Commission’s Medical Devices Coordination … It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.. It is vitally important to know the correct medical device classification for your product before CE marking your device. However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry. All regulatory documents shown below were published by the European Parliament or European Commission. The EU Medical Devices Regulation (MDR 2017/745) On April 5, 2017, the EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive. Innovation. Unusually, the New Regulation took effect on the date of its publication in the … The European Union (EU) Medical Device Regulation (MDR) is due to take full effect in May 2020, and its new scope includes a large number of products and devices that were outside the scope of the EU Medical Device Directive (MDD). Regulation (EU) No. Regulation (EU) 2017/745 The European Union Medical Device Regulation of 2017 If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to … According to FDA definition, a device is: Follow the update of the regulation in Medical Device. EU Medical Device Regulatory Services. This training is the first peek into this uncharted realm. Are you trying to get certified for ISO 13485 or about to get audited by a foreign health authority. The European Medical Devices Regulation (EU) 2017/745 (EU MDR) and In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (EU IVDR) in combination with the General Data Protection Regulation (EU) 2016/679 (GDPR) contain requirements for artificial intelligence in healthcare to be safe and performant. Compliance Management . Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations. These requirements, both ex ante and ex post requirements, ensure medical devices … While MedTech Europe considers the information herein to be reliable it makes no warranty or representation as to its accuracy, completeness or correctness. Please help us maintain this list by reporting outdated or missing documents. Overview of requirements under the Medical Devices Regulation 2017/745/EU. “The medical device industry in Europe confirms that without immediate action by the European Commission, the new regulatory system will not be ready on time to ensure continued access of patients and healthcare systems to life-saving and life-transforming devices. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. 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. Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. The regulation was published on 5 May 2017 and came into force on 25 May 2017. The EU Medical Devices Regulation will come into force on 26 May 2021 (Credit: Pixabay) New EU rules for medical device manufacturers have been postponed by a year in a bid to prevent shortages in getting key equipment on the market during the coronavirus pandemic. Description: The objective of this course is to provide you with an overview of the EU MDR 2017/745. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. 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