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Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on …
Medical Devices - Sector - Public Health
- https://health.ec.europa.eu/medical-devices-sector_en
- The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New Regulations …
B COUNCIL DIRECTIVE 93/42/EEC of 14 June …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
- medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; …
ANNEX II Medical Device Directive - EC DECLARATION OF …
- https://lexparency.org/eu/31993L0042/ANX_II/
- The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned meet …
Guide to Medical Device Directive Compliance …
- https://instrktiv.com/en/medical-device-directive/
- The Medical Devices Directive (MDD) is a European CE-Directive that is replaced by the Regulation (EU) 2017/745 . Medical Devices Directive (MDD) has a wide scope and its …
MEDICAL DEVICES Guidance document …
- https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
- Conformity assessment is the method by which a manufacturer demonstrates that their devices comply with the requirements of Directive 93/42/EEC. The classification of the …
Machinery Directive: What Applys to Medical Devices?
- https://www.johner-institute.com/articles/product-development/and-more/the-machinery-directive-which-parts-apply-to-medical-devices/
- If your medical device might be machinery as defined by the Machinery Directive, follow these five steps to demonstrate conformity: a) Step 1: check whether your device is …
Medical Device Directive (MDD)
- https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf
- Determine device classification Choose conformity assessment procedure Select Notified Body Implement QMS Prepare Technical File (TF) or Design Dossier Appoint an …
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