European Commission Medical Device Directive

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Directives - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives_en

The European Commission has adopted several implementing measures based on the medical devices directives. These measures concern, among other things, medical devices manufactured using tissues of animal origin, the classification of certain medical devices, and common technical specifications for in vitr… See more

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The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...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

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 …

New Regulations - Public Health

https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose …

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, …

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 …

Medical Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021.. The Medical Device Regulation (MDR), which was …

EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. THE COUNCIL OF THE EUROPEAN COMMUNITIES, ... 'If the appliance is at the same time …

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 …

MEDICAL DEVICES Guidance document …

https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native

EUROPEAN COMMISSION . DG HEALTH AND CONSUMER ... The present MEDDEV is part of a set of guidelines relating to questions of application of EU Directives on medical …

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