Medical Device Directive Official Journal

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Medical devices - Internal Market, Industry, Entrepreneurship and …

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169 of 12 July 1993. Applicable until 25.05.2021. See references published under Directive …

Official Journal L 90I/2020 - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L:2020:090I:FULL

Mar 24, 2020

EUR-Lex - L:2017:117:TOC - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC

Contents. I Legislative acts. page. REGULATIONS. *. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending …

Harmonised standards - Public Health

https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en

The publications in the OJEU of references of harmonised standards under the medical devices regulations are available: For Regulation (EU) 2017/745 Search for …

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; …

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 …

IV diagnostic medical devices - Internal Market, Industry ...

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en

Publications Publications in the Official Journal Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical …

Implantable medical devices - Internal Market, Industry ...

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/implantable-medical-devices_en

European standards Harmonised Standards Active implantable medical devices Active implantable medical devices Directive 90/385/EEC The references published under …

DIRECTIVE 98/79/EC OF THE EUROPEAN …

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079

7.12.98 EN Official Journal of the European Communities L 331/3 standards in accordance with the general guidelines on cooperation between the Commission and those two …

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