European Commission Harmonised Standards Medical Devices

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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 available translations of the preceding link EN ••• on medical devices: Commission …

Medical devices - Internal Market, Industry, Entrepreneurship and …

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

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the …

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 Visit page Details Publication date 17 May 2022 Author Directorate-General …

MDCG 2021-5 Guidance on standardisation for medical …

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

Harmonised European standards in the field of healthcare engineering, including medical devices, are developed by the two relevant European standardisation organisations …

Consolidated TEXT: 32020D0438 — EN — 15.04.2021

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02020D0438-20210415

The harmonised standards for active implantable medical devices drafted in support of Directive 90/385/EEC and listed in Annexes I and II to this Decision may not …

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

New 2020 lists of harmonised standards for medical devices are now available Internal Market, Industry, Entrepreneurship and SMEs Home News New 2020 …

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

Harmonised Standards - Internal Market, Industry, …

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

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

MDCG 2023-3 Questions and Answers on vigilance terms …

https://health.ec.europa.eu/system/files/2023-02/mdcg_2023-3_en_0.pdf

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of …

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