II.C.3. Analysis of the regulatory landscape

Estimated Execution Time

2 weeks

Objective

To analyse the regulatory landscape relevant to the identified unmet need in order to define regulatory boundaries, constraints, and risks for the PCP or PPI process. This step ensures that regulatory requirements are understood early, proportionally integrated into project design, and clearly distinguished from certification activities that fall outside the instrument.

Notice that for PCP, the focus is on understanding the regulatory path and constraints, as CE marking or full certification should typically take place after the R&D and proof of concept phases.
For PPI, solutions should generally already be CE-marked or compliant, and regulatory readiness should be part of eligibility criteria.

Who is Involved

Project Department / Innovation Unit: coordinate the regulatory analysis and ensure integration into project design.
Legal and Regulatory Experts: analyse applicable EU and national regulatory frameworks and compliance pathways.
Technical and Clinical Experts: support definition of intended use and regulatory classification assumptions.
Procurers / Contracting Authorities: validate regulatory assumptions against procurement scope and timelines.
Supporting Entities / Knowledge Partners (consultants, regulatory specialists): support roadmap development and risk assessment.

Activities / Tasks

II.C.3.1. Define regulatory boundaries based on the unmet need

Identify which regulated domains may be triggered by potential solution types (e.g. medical device, AI system, digital health tool).
Define regulatory assumptions and possible classification scenarios without fixing intended use prematurely.
Distinguish regulatory expectations for PCP versus PPI.

II.C.3.2. Map applicable regulatory frameworks

Identify relevant EU and national frameworks (e.g. MDR, IVDR, AI Act, GDPR).
Clarify ethics committee, patient protection, and data governance requirements for pilots.
Flag upcoming regulations that may affect timing or feasibility.

II.C.3.3. Define a proportional regulatory approach

Ensure the PCP does not require full CE marking or complete certification.
For PPI, clarify that regulatory compliance or CE marking may be required.
Consider requesting a regulatory pathway strategy from providers in the tender.
Integrate regulatory constraints into timeline and risk planning.

Tips / Common Pitfalls

✅Address regulatory aspects early to avoid delays during later phases, using regulatory analysis to support realistic timelines and budgets

✅Clearly distinguish what can be covered within PCP/PPI and what falls beyond the project scope.

❌Avoid assuming regulatory compliance without evidence or expert input

❌Do not overburden the PCP with full certification requirements when not feasible.

❌Avoid neglecting national regulatory differences in cross-border projects.

Outcome / Deliverables

Regulatory landscape understanding and implication in the PCP/PPI phases and timelines, to have it into account in the proposal design.

Resources

Regulatory Resources Repository

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