European Medicines Agency Medical Device

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Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

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 …

European Medicines Agency

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

On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a multi …

Quality documentation for medicinal products when used …

https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device-scientific-guideline

This guideline describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal product when it is used with a …

Regulation on EMA’s extended mandate becomes …

https://www.ema.europa.eu/en/news/regulation-emas-extended-mandate-becomes-applicable

EMA is now responsible for monitoring medicine shortages that might lead to a crisis situation, as well as reporting shortages of critical medicines during a crisis. The …

What we do | European Medicines Agency

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

provide medical advice. Healthcare professionals can provide individual patients advice on medical conditions, treatments or side effects with a …

Medicines and Medical Devices | Fact Sheets on the …

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

A. General rules on medicines A medicinal product (medicine) is a substance or combination of substances that is used for the treatment or prevention of diseases in …

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 …

Europe CE Marking Regulatory Process for …

https://www.emergobyul.com/resources/europe-ce-marking-regulatory-process-medical-devices

Europe CE Marking Regulatory Process for Medical Devices This certification verifies that a device meets all regulatory requirements of the medical devices …

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