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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 …

Medical Devices Directive - Wikipedia

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

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

      https://www.legislation.gov.uk/eudr/1993/42/2020-12-31
      Council Directive 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty …

    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 …

    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 …

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

      https://eur-lex.europa.eu/legal-content/EN/LSU/?uri=CELEX%3A31993L0042
      In 2013, the Commission adopted an implementing act, Implementing Regulation (EU) No 920/2013 on designating and supervising notified bodies under …

    MEDICAL DEVICES Guidance document …

      https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
      Conformity assessment is the method by which a manufacturer demonstrates that their devices comply with the requirements of Directive 93/42/EEC. The classification of the …

    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 …

    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/annex/I/division/I
      4.The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the …



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