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ANNEX I Medical Device Directive - ESSENTIAL …

    https://lexparency.org/eu/31993L0042/ANX_I/
    ANNEX I — ESSENTIAL REQUIREMENTS. I. GENERAL REQUIREMENTS. M5. 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 …

ANNEX X Medical Device Directive - CLINICAL EVALUATION

    https://lexparency.org/eu/31993L0042/ANX_X/
    Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2. In the case of implantable devices and devices in Class III clinical investigations shall be performed …

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

    https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
    medical devices (3) is the first case of application of the new approach to the field of medical devices; whereas in the interest of uniform Community rules applicable to …

ANNEX II Medical Device Directive - EC DECLARATION OF …

    https://lexparency.org/eu/31993L0042/ANX_II/
    ANNEX II — EC DECLARATION OF CONFORMITY. The manufacturer must ensure application of the quality system approved for the design, manufacture and final …

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 …

ANNEX IX Medical Device Directive - CLASSIFICATION …

    https://lexparency.org/eu/31993L0042/ANX_IX/
    All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in …

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 …

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 Directive (MDD) …

    https://www.presentationeze.com/presentations/medical-device-validation/medical-devices-directive-mdd-9342eec-explained/
    In the Medical Device Directive M.D.D. 93/42/EEC there are defined articles and annex’s which detail the requirements for compliance within the …

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/
    10.2. The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device. 10.3. The …



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