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Europe does not lack regulation – it lacks regulatory clarity early enough to support decisions.
For EDIHs, universities and incubators, and all regulatory sandbox operators, this creates a constant challenge:
supporting innovators without a scalable way to explain complex regulations and a triage layer to ensure their viability.
We are not proposing another project.
We are proposing a model that keeps regulatory clarity alive throughout and between projects.
As already validated with HealthHub Finland and Finnish AI Region (FAIR) EDIHs.
All key regulations – immediately accessible
“Navigation through the regulatory landscape couldn’t be more pain-free.” – Sara Zullino, PhD, Scientific Lead AI for Medical Applications, EATRIS | European infrastructure for translational medicine
Entries provides structured access to major EU regulations:
- AI Act
- Data Act
- European Health Data Space (EHDS) Regulation
- Medical Device Regulation (MDR)
- In Vitro Diagnostic Medical Device Regulation (IVDR)
SMEs, research teams and students can use these tools directly – making regulation part of everyday work, not a late hurdle.
We make regulatory clarity the default skill of future European innovators and industry.
Delivered across the year for less effort and cost per institution than a single regulatory expert engagement, while enabling your network to support hundreds and thousands of innovators at once.
Health tech pilot – from rules to real decisions
Health tech serves as the pilot sector.
In addition to core regulations, the “Regulatory Journey – Health Tech Startup” Entries tool enables innovators to generate a personalised regulatory strategy for their medical device.
To support adoption, we take the lead in organising:
- Frequent “Regulatory Essentials” sessions with
- Short Entries introductions
- Practical and personal guidance
- Verification of regulatory viability of the innovator team
Built to grow with your ecosystem
The more institutions and EDIHs join, the stronger you become:
- Shared learning across ecosystems
- Faster development
- Greater impact at scale
Enables Entries to expand with your needs:
- New regulatory domains: Cyber Resilience Act (CRA), GDPR, ESG and more
- Continuous improvement of highly deterministic regulatory models
- Increasing AI-assisted scalability and LLM powered guidance
Get in touch
Please fill in the contact form below and we’ll get back to you shortly.
In your message, include:
- your organisation or EDIH
- any questions, needs and ideas