European Medical Device Regulatory Agency

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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 …

Medical Device Regulation comes into application

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

Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May …

Medical Devices - New regulations - Public Health

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

An official website of the European Union Public Health Home Medical Devices - New regulations Medical Devices - New regulations Overview The EU has …

The Essential List of Regulatory Authorities …

https://www.raps.org/news-and-articles/news-articles/2020/1/the-essential-list-of-regulatory-authorities-in-eu

To ease the process of finding drug and medical device regulators in Europe, Focus has updated …

European Medicines Agency

https://www.ema.europa.eu/en

Public consultation on a multi-stakeholder platform to improve clinical trials in the EU On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European …

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 …

National competent authorities (human) | European …

https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human

List of national competent authorities in the EEA Information on coronavirus disease (COVID-19) The European Medicines Agency works closely with the national …

List of national authorities for Medical Devices

https://easymedicaldevice.com/list-national-authorities-medical-devices/

Federal Agency for Medicines and Health Products Health Products Division Place Victor Horta 40/40, 1060 Brussels Tel: +32 2 524 80 00 – Fax: +32 2 524 81 20 e-mail: …

Medical devices: EU regulations for MDR …

https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency ( MHRA) will continue to act as the Competent Authority for medical …

European Union | Regulatory Market Profile

https://www.rimsys.io/regulatory-market-profiles/european-union

European Union | Regulatory Market Profile European Union | Regulatory Market Profile Updated January 6, 2023 Regulatory Agencies & Related Organizations EC medical …

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