EU Regulatory Strategy & Roadmapping

Specculo's Regulatory Strategy & Roadmapping service gives MedTech innovators a clear, costed pathway to the European market. We start by understanding your device, its intended purpose and your business goals, then build a practical regulatory roadmap that sequences every milestone from classification through CE marking and market launch.

We confirm your device's risk class under EU MDR or IVDR, identify the applicable conformity assessment route, map notified body involvement and timelines, and flag where the AI Act or other product legislation (EMC, Radio Equipment, Low Voltage) applies. You receive a prioritised action plan with realistic timeframes, resource requirements and budget implications, so you can align regulatory, funding and commercial milestones with confidence.

We highlight the bottlenecks most companies underestimate, notably notified body capacity and technical documentation effort, and show you how to de-risk them early.

Throughout, you work directly with senior regulatory experts rather than a junior account team.

The service suits companies preparing for EU entry, refining an existing strategy, or aligning regulatory and fundraising timelines. Deliverables include a written regulatory strategy document, an annotated roadmap, and a working session to align your team, with ongoing advisory support available as your programme progresses. The outcome is a defensible, transparent plan that turns EU regulation from a source of uncertainty into a predictable, manageable workstream.