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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; …
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 …
Download MDR - Medical Device Regulation
- https://www.medical-device-regulation.eu/download-mdr/
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and …
Medical Device Directive (MDD), Directive 93/42/EEC - Lexparency
- https://lexparency.org/eu/31993L0042/
- Medical Device Directive (MDD), Directive 93/42/EEC Concerning medical devices Medical Device Directive – MDD Recitals Article 1 — Definitions, scope Article 2 …
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