Ema 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 framework for medical devices, introducing new responsibilities for EMA and national …

Medical Device Regulation comes into application

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

The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new …

European Medicines Agency

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

EMA Committee for Advanced Therapies elects Ilona Reischl as its new Chair. At its January 2023 meeting, EMA’s Committee for Advanced Therapies (CAT) elected Ilona …

EUDAMED database - EUDAMED - European Commission

https://ec.europa.eu/tools/eudamed/

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices ( Regulation (EU) 2017/745) and in vitro …

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 …

QWP-BWP Guideline on medicinal products used …

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

the medical device is packed together with the medicinal product (hereafter called co-packaged), or • Medicinal products, where the product information refers to a specific …

EudraGMDP database | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/eudragmdp-database

This content applies to human and veterinary medicines. The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, …

Human medicines: regulatory information | European …

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

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 …

Emergency Use Authorizations for Medical …

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices

2015 Enterovirus D68 (EV-D68) Emergency Use Authorization. On February 6, 2015, pursuant to section 564 (b) (1) (C) of the Act (21 U.S.C. § 360bbb-3 (b) (1) (C)), …

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