The RIS Database is a central resource offering detailed regulatory information for drug and medical device development across 27 European countries. It provides free access to regulatory requirements, guidelines and legislations, both at the EU and national level, with regular updates managed by CZECRIN regulatory specialists.
Successfully translating research into clinical practice for patient benefit requires navigating the complex regulatory landscape. The RIS Database supports professionals throughout this essential process.
Why regulatory support matters
Navigating the EU regulatory landscape is increasingly complex, especially for advanced or hybrid biomedical products. Delays, penalties or missed opportunities often stem from poor understanding of national or European requirements.
The EATRIS Regulatory Service and Support Centre is here to help. From expert advice to structured regulatory guidance, we connect researchers with tools to move forward confidently.
About the RIS Database
The Regulatory Information System (RIS) is a free-access online database covering regulatory requirements for:
RIS helps you:
- Medicinal products, medical devices, blood derivatives, tissues and cells
- Across 27 EU countries + Norway, Switzerland, Turkey and Israel
- Including emerging technologies: ATMPs, nanotechnologies, m-health…
- Understand local and EU-level regulatory pathways
- Reduce project delays and compliance risks
- Access updated national guidelines, laws, frameworks
Regulatory challenges in the EU
Despite ongoing harmonisation efforts, national fragmentation persists. RIS helps researchers:
Especially relevant for:
- Identify country-specific requirements
- Understand implications of cross-border trials
- Plan ahead for regulatory-critical milestones
- Early-stage biomedical projects
- Hybrid or next-generation technologies
- Multinational research initiatives
CREATIC | CZECRIN Role
CREATIC and CZECRIN support the promotion and onboarding of Czech regulatory infrastructure into RIS.
- Mapping and sharing Czech expertise
- Connecting national institutions to European initiatives
- Supporting researchers in navigating RIS and regulatory processes
Need help with RIS? Contact us directly and we’ll support your next steps.
