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Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active …
Medical Device Regulation comes into application
- https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
- Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. The …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- The Medical Device Coordination Group (MDCG) approved two further documents clarifying the timelines and requirements for using the EUDAMED database: Document 2019-4 …
B COUNCIL DIRECTIVE 93/42/EEC of 14 June …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
- medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; …
Your Guide to European CE Mark for Medical Devices - Essenvia
- https://essenvia.com/blog/eu/your-guide-to-european-ce-mark-for-medical-devices
- The European Union Medical Devices Regulations (EU MDR) replaced the MDD in May 2021. For this article, we will refer to current regulations outlined by the EU …
Guide to Medical Device Directive Compliance …
- https://instrktiv.com/en/medical-device-directive/
- The Medical Devices Directive (MDD) is a European CE-Directive that is replaced by the Regulation (EU) 2017/745 . Medical Devices Directive (MDD) has a wide scope and its …
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 “New …
MEDICAL DEVICES Guidance document …
- https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
- For medical devices of classes IIa, IIb and III, Member States may request to be informed of all data allowing for identification of such devices together with the label and the …
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