Medical Directive Harmonised Standards

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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 basis of a Standardisation Request issued by the Commission according to Regulation (EU) No …

MDCG 2021-5 Guidance on standardisation for medical …

https://health.ec.europa.eu/document/download/59ac4cb0-f187-4ca2-814d-82c42cde5408_en

3.2. Development of harmonised European standards for medical devices and assessment by the HAS consultants 3.3. Publication in the OJEU of references to …

EUR-Lex - 02020D0437-20210415 - EN - EUR-Lex

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02020D0437-20210415

Apr 15, 2021

Harmonized Standards List - Medical Device Regulation

https://www.medical-device-regulation.eu/mdr-resource-harmonized-standards-lis/

Below the list of harmonized standards for medical device for your reference and search. For latest update check the official page. Title of the standard. EN 285:2006+A2:2009 …

Harmonised Standards - Internal Market, Industry, …

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

Harmonised Standards. A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created …

New publication of Harmonised standards under the medical …

https://health.ec.europa.eu/latest-updates/new-publication-harmonised-standards-under-medical-devices-regulations-2022-05-17_en

New publication of Harmonised standards under the medical devices Regulations; News announcement 17 May 2022 Directorate-General for Health and Food …

New 2020 lists of harmonised standards for medical devices are …

https://single-market-economy.ec.europa.eu/news/new-2020-lists-harmonised-standards-medical-devices-are-now-available-2020-03-26_en

News. New 2020 lists of harmonised standards for medical devices are now available. Press release 26 March 2020 Directorate-General for Internal Market, …

EUR-Lex - 32020D0439 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?toc=OJ%3AL%3A2020%3A090I%3ATOC&uri=uriserv%3AOJ.LI.2020.090.01.0033.01.ENG

Article 1. The references of the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC and listed in Annex I to this Decision are …

Medical devices - Internal Market, Industry, Entrepreneurship and …

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

Short name: Medical devices. Base: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, …

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