European Medical Devices 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 …

European Medicines Agency

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

Additional responsibilities for monitoring and mitigation shortages of critical medical devices during public health emergencies now apply. CTIS now mandatory for new trial …

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 …

What we do | European Medicines Agency

https://www.ema.europa.eu/en/about-us/what-we-do

The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of …

Medical Devices - New regulations - Public Health

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

Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746. News …

Medicines | European Medicines Agency

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

Medicines under evaluation. National registers. Search. For help on how to get the results you want, see our search tips. Categories. Human (10107) Veterinary (1267) Herbal (199) …

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 …

National competent authorities (human) | European …

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

The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) ... Agency for medicinal …

Human medicines: regulatory information | European …

https://www.ema.europa.eu/en/human-medicines-regulatory-information

This section of the website provides information on the regulation of medicines for human use in the European Union (EU). It particularly concerns the centralised procedure, …

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 its list of the website(s) for each country’s ministry of health …

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