EDIH Summit 2026 Finalist: Simplifying Regulatory Compliance

This recognition belongs to HealthHub Finland EDIH (HHFIN) and the joint work behind the initiative “Towards Simplified Regulatory Compliance: A Comprehensive Digital Tool for Innovators”—where we’ve contributed to expanding the Entries e-tool across frameworks such as the AI Act, Data Act, EHDS Regulation, MDR and IVDR. This collaborative effort has been supported along the way by various public organizations including the Finnish AI Region (FAIR EDIH).

What stands out is the broader momentum across Europe where EDIHs and AI initiatives are coming together to help innovators and SMEs navigate regulatory complexity and succeed in the market.

One of the key challenges that remains is ‘regulatory clarity’—not the regulations themselves, but the ability to understand and act on them early. It’s encouraging to see that this challenge is being recognized and that practical solutions are moving forward.

What is Lean Entries?
Lean Entries is the digital sandbox within its parent company Aurevia that drives this mission forward by equipping teams with Entries e-tools that translate complex regulations into step-by-step actionable guidance. 

Do you need support with quality, regulatory or clinical development? Aurevia has the expertise to support your entire product lifecycle. Reach out so we can discuss your needs.