Eu Regulation Medical Devices

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Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national …

Medical Devices - New regulations - Public Health

https://health.ec.europa.eu/medical-devices-new-regulations_en

26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU. News announcement.

New Regulations - Public Health

https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

EUR-Lex - 32017R0745 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic …

Medical Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021.. The Medical Device Regulation (MDR), which …

Medical Devices - New regulations - Latest updates

https://health.ec.europa.eu/medical-devices-new-regulations/latest-updates_en

COM (2021)627 - Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro …

EUR-Lex - 32021R2226 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/eli/reg_impl/2021/2226/oj

L 448/32. COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226. of 14 December 2021. laying down rules for the application of Regulation (EU) 2017/745 of the European …

Medical Devices - Sector - Latest updates - Public Health

https://health.ec.europa.eu/medical-devices-sector/latest-updates_en

Medical Devices - Sector - Latest updates. MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to …

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 …

Regulation (EU) 2017/745 - Wikipedia

https://en.wikipedia.org/wiki/Regulation_(EU)_2017/745

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC …

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