The RIS Database is a central resource offering detailed regulatory information for drug and medical device development across 27 EU countries (as well as Norway, Switzerland, Turkey, Israel and the United Kingdom). 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.
If you do not receive your login credentials within one week of submitting the form, please contact us at ris@eatris.eu.
Why regulatory support matters?
Navigating the EU regulatory landscape is increasingly complex, especially for advanced or hybrid 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:
- Medicinal products, medical devices, blood derivatives, tissues and cells...
- Across 27 EU countries + Norway, Switzerland, Turkey, Israel and the United Kingdom
- Including emerging technologies, such as cell and gene therapies
RIS helps you:
- 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:
- Identify and comply country-specific requirements
- Facilitation of multi-national collaboration
- Plan ahead for regulatory-critical milestones
Especially relevant for:
- 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.
- Regulatory specialists from CZECRIN and CREATIC ensure the regular updates of the database to provide up-to-date information in line with regulatory requirements across Europe.
- Mapping and sharing Czech expertise
- Connecting national institutions to European initiatives
- Supporting researchers in navigating RIS and regulatory processes
EATRIS – European Infrastructure for Translational Medicine
EATRIS is a European research infrastructure supporting the translation of biomedical discoveries into clinical applications. The RIS database is one of its key tools for navigating regulatory requirements across Europe.
More about EATRIS →
CZECRIN – Czech Clinical Research Infrastructure Network
CZECRIN connects academic institutions and healthcare facilities across the Czech Republic, facilitating clinical trials and supporting researchers in regulatory and methodological aspects.
More about CZECRIN →
