Eu Official Journal Medical Devices

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Medical devices - Internal Market, Industry, Entrepreneurship and …

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

Publications in the Official Journal. Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of …

Harmonised standards - Public Health

https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en

For Regulation (EU) 2017/746 on in vitro diagnostic medical devices: Commission Implementing Decision (EU) 2022/729 of 11 May 2022 Commission …

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

The European Union Medical Device Regulation – …

https://eumdr.com/

The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices …

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 …

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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 …

MDR harmonised standards update | mdi …

https://mdi-europa.com/mdr-harmonised-standards-update/

by Michael Sander Harmonisation of standards under Regulation (EU) 2017/745 on medical devices (MDR) is further progressing. The table below …

European Commission publishes second batch of …

https://www.raps.org/news-and-articles/news-articles/2022/1/european-commission-publishes-second-batch-of-harm

The European Commission on Tuesday officially recognized nine harmonized standards for medical devices that device makers can reference in order to satisfy …

Official Journal of the European Union - European …

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

Official Journal of the European Union | European Medicines Agency Official Journal of the European Union Daily European Union publication publishing legal instruments and …

The European Union In Vitro Diagnostics Regulation

https://euivdr.com/

Publication of MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in …

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