Modelling regulatory sandbox mechanisms and enabling their deployment to support breakthrough innovation

Last updated: 16.7.2025
Grant

This funding program, under the Innovative Health Initiative (IHI) Joint Undertaking, focuses on modelling and deploying regulatory sandbox mechanisms to accelerate breakthrough healthcare innovations. It aims to foster a shared understanding of these flexible regulatory frameworks and support their efficient implementation within the EU healthcare ecosystem. The initiative seeks to bridge the gap between rapidly evolving health technologies and the regulatory environment, promoting a more innovation-friendly landscape in Europe.

Who is Funded

This section details the eligible entities and geographical scope of the program, outlining who can apply and where project activities must take place. It also clarifies the overarching objectives and strategic impact the program aims to achieve in the healthcare innovation landscape.

What is Funded

This section outlines the types of projects and thematic areas eligible for funding, focusing on breakthrough innovations in healthcare. It also provides information on the expected maturity level of supported projects.

Type and Scope of Funding

This section provides information on the financial support available, including the type of financial instrument and the maximum funding amount per project.

Conditions and Requirements

This section outlines the essential rules and conditions that applicants and beneficiaries must adhere to, covering application terms, consortium requirements, and budget stipulations.

Application Procedure

This section outlines the detailed steps for submitting a proposal, from preparing documents to understanding the evaluation and selection process. It also highlights where applicants can find essential templates and guidance.

This section identifies the fundamental legal instruments and overarching policies that underpin and govern the funding program, ensuring its mandate and operational framework are clearly defined.

Similar Programs

#regulatory sandboxes#healthcare innovation#EU funding#breakthrough innovation#medical devices#pharmaceuticals#Horizon Europe#IHI JU#digital health#AI in healthcare#regulatory framework#innovation policy#research grants#consortium funding#medical biotechnology#health technology assessment#clinical studies#innovation ecosystem

Funding Overview

Funding Status

Funding Status:

Closed

Maximum Amount

Maximum Amount:

5,200,000 €

Allocated Budget

Allocated Budget:

5,200,000 €

Award Channel

Award Channel:

Framework Programme Call

Region

Region:

European Union and Associated Countries

Sectors

Sectors:

Healthcare, Medical Technology, Pharmaceutical Industry, Research and Development, Information and Communication Technology, Other

Beneficiaries

Beneficiaries:

Healthcare, patients, clinicians, small and medium-sized enterprises (SMEs), academics, regulators, health technology assessment bodies (HTAs).

Application Type

Application Type:

Consortium Required

Funding Stages

Funding Stages:

Applied Research, Experimental Development, Prototyping, Pilot Testing, Product Development, Market Introduction

Funding Provider

Program Level:

European Union

Funding Body:

European Commission, Innovative Health Initiative Joint Undertaking (IHI JU)

Managed By:

Innovative Health Initiative Joint Undertaking (IHI JU)

0 x 0
XS