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Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national …
Medical Device Regulation comes into application
- https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
- The MDR replaces the existing Directives for medical devices (93/42/EEC and 90/385/EEC). The Regulation on in vitro diagnostic medical devices, which also …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- A second c orrigendum to Regulation (EU) 2017/745 was published in the Official Journal of the European Union. Probably the most significant change being the extension of the …
Medical devices - Internal Market, Industry, Entrepreneurship and …
- https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en
- Short name: Medical devices. Base: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, …
B COUNCIL DIRECTIVE 93/42/EEC of 14 June …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
- B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) Amended by: Official Journal No page date M1 …
What Is the EU Medical Devices Directive? | Assent
- https://www.assent.com/resources/knowledge-article/what-is-the-eu-medical-devices-directive/
- The European Union (EU) Medical Devices Directive (MDD) was introduced in 1994 to regulate medical devices sold in the EU. The MDD is based on the principles of the …
European Medical Device Regulation | Deloitte Netherlands
- https://www2.deloitte.com/nl/nl/pages/risk/articles/european-medical-device-regulation.html
- The European Medical Device Regulation 2017/745 (EU-MDR) provides a regulatory framework with the purpose of ensuring safe and effective performance of medical …
Guide to Medical Device Directive Compliance …
- https://instrktiv.com/en/medical-device-directive/
- Medical Device Directive (93/42/EEC) - Certification Guide. 28/5/2019 Ferry Vermeulen Law & Legislation. 1. What is the Medical Devices Directive. The Medical Devices …
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