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The central point of support for EUDAMED users, presenting action steps and process logic from a wide range of documentation – including a detailed FAQ section and a library of all platform user guides. EUDAMED is the database of Medical Devices available on the EU Market.
- Getting Started
Getting Started - Welcome to the EUDAMED information centre...
- Data Exchange
Data Exchange - Welcome to the EUDAMED information centre -...
- Search by Module
Search by Module - Welcome to the EUDAMED information centre...
- Actor
Actor - Welcome to the EUDAMED information centre - Europese...
- Documentation
Documentation - Welcome to the EUDAMED information centre -...
- Frequently Asked Questions
The FAQ homepage draws answers from the entire archive....
- Getting Started
Regulation (EU) No. 536/2014 on clinical trials on human medicines (the 'Clinical Trials Regulation') provides a legal basis for the release of clinical trial results conducted in the European Union (EU) and authorised under this Regulation. It entered into application on 31 January 2022.
For further information on EUDAMED, please visit the medical devices section of the European Commission website. Access to MDR EUDAMED is restricted to users identified by their EU Login account. Make sure your Actor registered in EUDAMED has at least 2 active Local Actor Administrators (LAA).
31 sty 2022 · The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission. CTIS went live with a searchable public website on 31 January 2022.
16 gru 2022 · Functional specifications for the European Database on Medical Devices (EUDAMED)
Single EU portal and database to support: One application dossier for each clinical trial or modification. Coordinated approach to clinical trial assessment, authorisation and supervision. Transparency of clinical trial information.
EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the database for all interventional clinical trials on medicinal products submitted to the National Competent Authorities (NCAs) of the European Union (EU)/European Economic Area (EEA) from 1 May 2004 until 30 January 2023 under Directive 2001/20/EC, as well as for ...