A free reference book
From CE Mark to Revenue
The regulatory and commercial route for medical devices, software and in vitro diagnostics in the European Union
Daren Wilson, Co-founder and Senior Partner, HealthSeed AG
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HealthSeed AG, which publishes this book, launched Venitara with Mangold Consultants.
What this book is
This book explains how a medical device or in vitro diagnostic (IVD) company gets from a CE mark, or the plan for one, to paying customers in the European Union. An IVD is a product used to test samples taken from the body, such as blood. The CE mark is the marking most devices must carry to be sold in the Union. By affixing it, the manufacturer declares that the device meets the requirements of the applicable Regulation.
The book covers the two laws that decide whether a product can be CE marked. These are the Medical Device Regulation, Regulation (EU) 2017/745 (MDR), and the In Vitro Diagnostic Medical Device Regulation, Regulation (EU) 2017/746 (IVDR).
It then follows the product past certification, into the steps between a CE mark and revenue. These are Union health technology assessment, the joint EU review of how well a product works compared with existing care; national reimbursement routes; public procurement; channel and price decisions; and the cost and funding of entry.
It is a reference work, built so that a reader can go straight to the chapter that matters now; nothing depends on reading the book in order. Each chapter answers one question that founders, regulatory leads, market access teams, and investors ask during market entry. The chapter opens with the short answer and then sets out the rules and guidance that support it.
The chapters
Stage 1Decide what you are bringing to market
Stage 2Build the system and the evidence
Chapter 4
What quality system does the law require, and who answers for it?
Chapter 5
Which standards do the risk, usability, software and security files rest on, and how is the answer kept current?
Chapter 6
What evidence shows the device is safe and works, and how is it kept current?
Chapter 7
What goes into the technical documentation, and how is it kept current?
Stage 3Certify and register
Stage 4Reach patients and payers
Chapter 11
After launch, what must a manufacturer monitor, report and correct?
Chapter 12
Does Union health technology assessment reach the product?
Chapter 13
Which national route does the product take, and who pays at the end?
Chapter 14
Which economic evidence can be built once, and what does each country set?
Chapter 15
How do public buyers purchase the product, and what must be ready before the notice?
The PDF edition
Get the book
Enter your name and email and the PDF downloads straight away. It is the complete book, with every chapter’s sources gathered at the back, free under CC BY 4.0.
PDF, 18.5 MB. First edition, October 2026.
About the author
Daren Wilson is co-founder and Senior Partner of HealthSeed AG, a Swiss healthcare venture studio and commercialisation partner based in Zürich.
He spent more than 20 years in pharmaceutical commercial leadership at Roche and Novartis, including General Manager roles in Slovakia and Indonesia, with responsibility for launches, market access and commercial strategy across several health systems. He was Vice-President of the American Chamber of Commerce in Slovakia and founded the European HealthcareLab start-up accelerator.
His work now sits in the gap between regulatory approval and revenue, the stretch of market entry where, in his experience, health innovations most often stall. He writes and speaks on scaling health innovation in Europe, on AI in healthcare, and on how Europe's health innovation system works in practice.
Contact: daren.wilson@healthseed.vc
About HealthSeed
HealthSeed AG is a Swiss healthcare venture studio and commercialisation partner. It helps biotech, medtech, diagnostics and digital health companies launch and scale across Europe, North America and the Middle East and North Africa, with senior operators, an integrated specialist network and pricing tied to the client's commercial outcomes.
HealthSeed works across three pillars. International healthcare commercialisation takes companies into new markets, in both directions between the United States and Europe. Joint ventures and AI products build new businesses with partners; one of them is Venitara, a regulatory platform for device, software and IVD companies launched with Mangold Consultants. The expert ecosystem, a network of more than 35 regulatory, clinical and commercial specialists, supplies the depth each programme needs.
| Service | What it covers |
|---|---|
| Strategic Assessment | Regulatory pathway, reimbursement landscape, competitive position and a phased market entry roadmap |
| EU Launchpad | Full European market entry in one programme, from strategy to commercial revenue |
| Focused GTM Execution | Targeted modules for companies already in a market: market access, hospital pilots and launch infrastructure |
| Bespoke Partnerships | Co-building ventures that have validated products but lack commercial infrastructure |
HealthSeed AG, Weidmannstrasse 5, 8046 Zürich, Switzerland. www.healthseed.vc, contact@healthseed.vc
Licence
Free to read, share and adapt under CC BY 4.0.
Published by HealthSeed AG, Weidmannstrasse 5, 8046 Zürich, Switzerland. www.healthseed.vc
© 2026 Daren Wilson. This work is licensed under the Creative Commons Attribution 4.0 International licence (CC BY 4.0), creativecommons.org/licenses/by/4.0. You may copy, share and adapt it for any purpose, including commercial use, provided you give appropriate credit, link to the licence and indicate whether changes were made.
Suggested citation: Wilson, D. (2026). From CE Mark to Revenue: the regulatory and commercial route for medical devices, software and in vitro diagnostics in the European Union. Zürich: HealthSeed AG.
The book is general information on the law and guidance as they stood on the check dates given in its sources. It is no substitute for legal, regulatory or reimbursement advice on a specific product. The four running cases are composites and describe no real company or product.
HealthSeed AG is a joint-venture partner in Venitara, whose services are described in the publisher's notes in chapters 1, 4, 5, 7 and 10. The publisher's notes in chapters 2, 13, 16 and 17 describe HealthSeed's own services. The cover and chapter-opening artwork was created with AI image generation.