Official Journal European Union Medical Devices

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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 …

Medical Devices - Sector - Public Health

https://health.ec.europa.eu/medical-devices-sector_en

Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023. News …

Medical devices - Internal Market, Industry, Entrepreneurship and …

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en

Medical devices. Base: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, ... The summary below consolidates the …

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 | 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 …

Official Journal L 90I/2020 - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L:2020:090I:FULL

Mar 24, 2020

EUR-Lex - L:2017:117:TOC - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC

Official Journal of the European Union, L 117, 5 May 2017. Display all documents published in this Official Journal. Expand all Collapse all. ... Regulation (EU) 2017/746 …

Harmonised Standards - Internal Market, Industry, …

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en

In vitro diagnostic medical devices (Regulation 2017/746) Medical devices (Regulation 2017/745) Active implantable medical devices (Directive 90/385/EEC) ... publication of …

Official Journal of the European Union - European …

https://www.ema.europa.eu/en/glossary/official-journal-european-union

Official Journal of the European Union. Daily European Union publication publishing legal instruments and other European Union documents. For more information, see ' …

The European Union In Vitro Diagnostics Regulation – …

https://euivdr.com/

The European Commission published MDCG 2019-16, Guidance on Cybersecurity for medical devices, including IVD medical devices. December 2019: A second …

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