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Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The medical device may be co-packaged with, obtained separately from or integral to the medicinal product. EMA issued a final guideline on quality documentation for medicinal products that include a medical device in July 2021. This clarifies expectations …

Directives - Public Health

    https://health.ec.europa.eu/medical-devices-sector/directives_en

    Medical devices - Internal Market, Industry, Entrepreneurship and …

      https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en
      Guidelines related to medical devices regulations; European Commission contact point: Directorate-General for Health and Food Safety Medical devices Email Webpage on …

    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      The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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 …

    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 Directive - Wikipedia

      https://en.wikipedia.org/wiki/Medical_Devices_Directive
      The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements …

    The European Union Medical Device Regulation – …

      https://eumdr.com/
      The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical …

    EU Medical Device Directives - 6 Key Elements to Ensure …

      https://www.complianceonline.com/resources/eu-medical-device-directives-key-elements.html
      How Does the EU Regulate Medical Devices? At present, the EU's regulatory framework for medical devices includes the following directives: Council Directive 90/385/EEC on …

    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 DEVICES Guidance document …

      https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
      For medical devices of classes IIa, IIb and III, Member States may request to be informed of all data allowing for identification of such devices together with the label and the …



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