Medical Device Directive Consolidated

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EUR-Lex - 02017R0745-20170505 - EN - EUR-Lex

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505

Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (2) shall, where a hazard relevant under that Directive exists, also meet the …

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 - 01993L0042-20071011 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01993L0042-20071011

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 …

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 …

EUR-Lex - 31998L0079 - EN - EUR-Lex - Europa

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

(a) 'medical device` means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its …

The European Union Medical Device Regulation – …

https://eumdr.com/

The Medical Device Coordination Group (MDCG), which has many responsibilities in the new Regulation, has now been established. It is listed in the register of Commission …

Medical Devices Directive - Wikipedia

https://en.wikipedia.org/wiki/Medical_Devices_Directive

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 [1] concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws …

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 basis of a …

Guide to Medical Device Directive Compliance …

https://instrktiv.com/en/medical-device-directive/

Medical Devices Directive (MDD) has a wide scope and its purpose is to ensure free movement of safe medical devices within the EU community. The directive requires all …

Council Directive 93/42/EEC of 14 June 1993 concerning …

https://www.legislation.gov.uk/eudr/1993/42/2020-12-31

HAS ADOPTED THIS DIRECTIVE: Article 1 Definitions, scope 1.This Directive shall apply to medical devices and their accessories. For the purposes of this …

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