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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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