MediRegs® European Device Regulation Library
All-in-one research tools for EU medical device compliance
The European Device Regulation Library is a one-stop resource for European medical device compliance research. Centralized search tools provide easy, effective access to all of the materials published by the European Union on the regulation of medical devices. It is the simplest way to find the current information you need from thousands of EU publications, guidance documents, reports and other regulatory resources.
- Stay on top of the rules governing the development and marketing of medical devices in the EU
- Quickly access data from thousands of key sources
- Receive continual updates from the agencies that directly regulate device manufacturing, sale and use in the EU
- Ensure compliance for your organization in its relationship with European manufacturers, suppliers, consultants, and customers
Easy access to detailed regulatory documents
The European Device Regulation Library gives you quick access to compliance information rules and guidelines from thousands of documents and diverse regulatory bodies. Resources span numerous agencies and document types.
- Councils and commission reports
- European Court of Justice opinions
- MedDev guidelines
- US NIST Guides to the EU device directives
- Global Harmonization Task Force documents
- Other important sources
Centralized searches for complex compliance issues
The European Device Regulation Library makes it easy to get the specifics you need using one robust set of integrated search tools. Easy Web links, extensive archives and fast searches save time and connect you quickly to regulatory information pertaining to international medical device compliance.
- Device classification
- Regulation of active implantable medical devices
- Regulation of in vitro diagnostic devices
- Medical devices vigilance systems
- "CE" marking
- Notified bodies and government contact points
- Other types of related regulatory data