European Regulatory Agency Medical Devices

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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 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 …

Medical Devices - Sector - Public Health

https://health.ec.europa.eu/medical-devices-sector_en

Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023. News …

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 …

European Medicines Agency

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

Human medicines: highlights of 2022. In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 41 1 had a new active substance which had never …

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 …

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 and regulatory …

Medicines and Medical Devices | Fact Sheets on the …

https://www.europarl.europa.eu/factsheets/en/sheet/50/medicines-and-medical-devices

Regulation (EU) 2017/745 and Regulation (EU) 2017/746 set the rules on placing medical and in vitro diagnostic devices on the market and on related clinical investigations. These …

The European Union Medical Device Regulation – …

https://eumdr.com/

A second c orrigendum to Regulation (EU) 2017/745 was published in the Official Journal of the European Union. Probably the most significant change being the extension of the …

List of national authorities for Medical Devices

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

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