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ANNEX VII Medical Device Directive - EC DECLARATION OF …

    https://lexparency.org/eu/31993L0042/ANX_VII/
    ANNEX VII — EC DECLARATION OF CONFORMITY M5. The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the …

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

    https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
    B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) Amended by: Official Journal No page date M1 …

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

    https://www.legislation.gov.uk/eudr/1993/42/2020-12-31
    ‘ If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC and if it satisfies the essential requirements laid down therein for …

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

    https://www.legislation.gov.uk/eudr/1993/42/contents
    Article 12. Particular procedure for systems and procedure packs and procedure for sterilisation. Article 12a. Reprocessing of medical devices. Article 13. Decisions with …

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

    https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042
    Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169, 12.7.1993, …

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 …

Column - MDD – Annex VII - MedTech Intelligence

    https://www.medtechintelligence.com/column/devine-guidance-mdd-annex-vii/
    MDD – Annex VII. The message of compliance remains consistent and will never change. The goal of any device regulation and regulatory body, regardless of the country of origin, is the protection of public health by ensuring medical devices are safe and effective. Annex VII (EC Declaration of Conformity) of Council Directive 93/42/EEC, …

MDD ANNEX VII. EC DECLARATION OF …

    https://www.presentationeze.com/presentations/medical-device-validation/medical-devices-directive-mdd-9342eec-explained/mdd-annex-vii-ec-declaration-conformity/
    1. MDD Annex VII, the EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by …

Medical Device Directive (MDD)

    https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf
    Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC. Slide 2 of 37 Robert Packard, Consultant www.MedicalDeviceAcademy.com [email protected] • …

MEDICAL DEVICES Guidance document …

    https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
    The manufacturer should first decide if the product concerned is a medical device as defined in Directive 93/42/EEC or an accessory to such a medical device, if it is not excluded …



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