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Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices. The In Vitro Diagnostic Devices Regulation applies since 26 May 2022. It repeals Directive 98/79/EC of the European …
EUR-Lex - 32011L0024 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32011L0024
- Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (19), Council …
EUR-Lex - 32017R0745 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
- 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 …
Clinical Trials Regulation | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
- On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- A second c orrigendum to Regulation (EU) 2017/745 was published in the Official Journal of the European Union. Probably the most significant change being the extension of 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 …
Harmonised standards - Public Health
- https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en
- Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the basis of a …
EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042
- COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. THE COUNCIL OF THE EUROPEAN COMMUNITIES, ... Whereas this Directive covers the …
B COUNCIL DIRECTIVE 93/42/EEC of 14 June …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
- M3 Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 L 6 50 10.1.2002 M4 Regulation (EC) No 1882/2003 of the European …
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