Official Journal Of The European Union 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

The publications in the OJEU of references of harmonised standards under the medical devices regulations are available: For Regulation (EU) 2017/745 Search for …

Medical Devices - Sector - Public Health

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

An official website of the European Union How do you know? en English Search Public Health Home Medical Devices - Sector Medical Devices - Sector …

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 for …

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

Medical devices | European Medicines Agency

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

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

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 Languages and formats …

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 …

5139/23, COM(23)10 EXPLANATORY MEMORANDUM FOR …

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1136556/230208_Annex_B_EM_February_2023_-_Transitional_Arrangements_-_OFFICIAL_SENSITIVE_-_FINAL.pdf

transitional provisions for certain medical devices and in vitro diagnostic medical devices. Submitted by the Department of Health and Social Care on 10 February 2023. SUBJECT …

Breaking News: EU Votes to Amend Medical Device …

https://www.linkedin.com/pulse/breaking-news-eu-votes-amend-medical-device-regulation-

1. Those devices must continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable. 2. There are no significant changes in the design and …

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