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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 …
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 European Union Medical Device Regulation – …
- https://eumdr.com/
- Press release 26 May 2021: announcing Stronger rules on medical devices (EU MDR) have entered into application. Publication of MDCG 2021-8 Clinical investigation …
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; …
Medical Devices - Sector - Public Health
- https://health.ec.europa.eu/medical-devices-sector_en
- The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New Regulations …
Harmonised standards - Public Health
- https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
- Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the …
EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042
- Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on …
List of Products Covered by the EU Medical Devices …
- https://www.compliancegate.com/medical-devices-directive-product-list/
- Medical masks are classified as Class I medical devices under the directive. They shall comply with applicable EN standards including EN 149 and EN 14683. Also, the masks shall be tested for 3 …
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