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ANNEX I Medical Device Directive - ESSENTIAL …

    https://lexparency.org/eu/31993L0042/ANX_I/
    A manufacturer's indication of single use must be consistent across the Community; B (g) if the device is costum-made, the words ‘custom-made device’; (h) if the device is …

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 …

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

    https://www.legislation.gov.uk/eudr/1993/42/2020-12-31
    Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the …

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 Directive …

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

    https://www.legislation.gov.uk/eudr/1993/42/contents
    Repeal and amendment of Directives Article 22. Implementation, transitional provisions Article 23. This Directive is addressed to the Member States. Expand + ANNEX I …

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

    https://lexparency.org/eu/31993L0042/
    Medical Device Directive – MDD. Recitals. Article 1 — Definitions, scope. Article 2 — Placing on the market and putting into service. Article 3 — Essential …

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

    https://www.legislation.gov.uk/eudr/1993/42/annex/I/division/I
    The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition …

MEDICAL DEVICE DIRECTIVE ANNEX I

    https://www.presentationeze.com/presentations/medical-device-validation/medical-devices-directive-mdd-9342eec-explained/medical-device-directive-annex-essential-requirements/
    If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and …

ANNEX IX Medical Device Directive - CLASSIFICATION …

    https://lexparency.org/eu/31993L0042/ANX_IX/
    ANNEX IX — CLASSIFICATION CRITERIA I. DEFINITIONS 1. Definitions for the classification rules 1.1. Duration Transient Normally intended for continuous use for less …

Medical Devices Directive (MDD) …

    https://www.presentationeze.com/presentations/medical-device-validation/medical-devices-directive-mdd-9342eec-explained/
    Medical Devices Directive (MDD) 93/42/EEC – Explained Information | Understanding | Best Practice. In the Medical Device Directive M.D.D. 93/42/EEC there are defined articles and …



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