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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 obligations imposed by Section 2 and, in the case of products placed on the …

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 Objectives of “New Approach” Adopted by all Member States Efficient regulation Ensure safe medical …

Regulation (EU) 2017/745 of the European Parliament …

    https://www.legislation.gov.uk/eur/2017/745/contents
    Unique Device Identification system Article 28. UDI database Article 29. Registration of devices Article 30. Electronic system for registration of economic operators Article 31. …

Guidance on Class I medical devices - GOV.UK

    https://www.gov.uk/government/collections/guidance-on-class-1-medical-devices



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