Medical Device Directive Annexes

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Comparison of the annexes of the European Medical Devices …

https://www.medical-device-regulation.eu/wp-content/uploads/2020/09/MDD_MDR_annexes_Comparison.pdf

comprises 23 Articles and 12 annexes over 60 pages, the MDR has 123 articles and 17 annexes over 175 pages. This table provides a comparison of some of the annexes of the MDD and MDR. The table is an excerpt from the MDR/IVDR Smart Support available in …

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 …

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 …

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 …

ANNEX IX Medical Device Directive - CLASSIFICATION …

https://lexparency.org/eu/31993L0042/ANX_IX/

ANNEX IX — CLASSIFICATION CRITERIA. 1. Definitions for the classification rules. 1.1. Duration. Normally intended for continuous use for less than 60 minutes. Normally …

Medical Device Directive (MDD)

https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf

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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 …

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 …

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 Devices Directive - Wikipedia

https://en.wikipedia.org/wiki/Medical_Devices_Directive

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating …

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