Medical Device Directive 93 42 Eec 2007

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B COUNCIL DIRECTIVE 93/42/EEC of 14 June …

https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article …

EUR-Lex - 32007L0047 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32007L0047

For the appropriate and efficient functioning of Directive 93/42/EEC as regards regulatory advice on classification issues arising at national level, in particular on whether or not a …

EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of …

Medical Devices Directive - Wikipedia

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

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 …

Medical Device Directive (MDD), Directive 93/42/EEC - Lexparency

https://lexparency.org/eu/31993L0042/

Medical Device Directive (MDD), Directive 93/42/EEC Concerning medical devices Medical Device Directive – MDD Recitals Article 1 — Definitions, scope Article 2 …

ANNEX IX Medical Device Directive - CLASSIFICATION …

https://lexparency.org/eu/31993L0042/ANX_IX/

Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered …

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 …

ANNEX X Medical Device Directive - CLINICAL EVALUATION

https://lexparency.org/eu/31993L0042/ANX_X/

All the appropriate features, including those involving the safety and performances of the device, and its effect on patients must be examined. M5 All serious adverse events must …

Medical Device Directive (MDD)

https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf

MDD 93/42/EEC Annex I Essential requirements Annex II EC declaration of conformity (Full quality assurance system) Annex III EC type-examination Annex IV EC verification Annex …

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