Contents
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.
What you can do with it#
The book is written for people who have to make or check an entry decision. A founder can use it to find out whether a product needs a notified body, an independent organisation, designated by a national authority, that must assess certain devices before they can carry the CE mark. The same founder can find which countries have a route by which a payer covers the product, or what a public tender will ask for before the notice appears.
A regulatory, clinical, or market access lead can use it to find the exact provision or guidance page behind a requirement, with a link to the official text. An investor or board member can use it to test whether an entry plan has reached each decision in the right order and on a sound basis.
Figure 0.1 shows the eighteen chapters as the route a product takes. The route starts with qualification and class, which means deciding whether the product is a medical device at all and which risk class it falls into, and ends with revenue and funding.
| Stage | No. | The question it answers |
|---|---|---|
| Decide what you are bringing to market | 1 | Is it a medical device, which class, and who is responsible? |
| 2 | Which market should come first, and on what evidence? | |
| 3 | How large is the opportunity, and what can the published figures support? | |
| Build the system and the evidence | 4 | What quality system does the law require, and who answers for it? |
| 5 | Which standards do the risk, usability, software and security files rest on, and how is the answer kept current? | |
| 6 | What evidence shows the device is safe and works, and how is it kept current? | |
| 7 | What goes into the technical documentation, and how is it kept current? | |
| Certify and register | 8 | Which notified body can assess the device, and how does the work with it run? |
| 9 | Who registers the company, its partners and each device, and by when? | |
| 10 | Which AI and cybersecurity rules reach the product, and from when? | |
| Reach patients and payers | 11 | After launch, what must a manufacturer monitor, report and correct? |
| 12 | Does Union health technology assessment reach the product? | |
| 13 | Which national route does the product take, and who pays at the end? | |
| 14 | Which economic evidence can be built once, and what does each country set? | |
| 15 | How do public buyers purchase the product, and what must be ready before the notice? | |
| Commercialise and fund | 16 | Which countries come first, and who sells at what price? |
| 17 | What will European market entry cost, what does it wait on, and who can pay? | |
| 18 | Which commitments in the entry programme should be checked before options close? |
How each chapter is organised#
Every chapter follows the same order and can be read on its own, without the chapters before it. Abbreviations are spelled out afresh in each chapter. It opens with an introduction that sets out the question, why it matters, and what the chapter covers.
A section headed "In short" follows. It answers the question in a few paragraphs that carry their own citations, written so that they can be quoted on their own. The body then takes the question apart, with a table wherever a comparison is clearer in rows than in prose and a figure wherever a decision has branches.
A section headed "How the answer is reached" sets out the order in which the decision is made. The chapter then applies that order to four running cases and names the points at which specialist help is worth paying for. It ends with a conclusion that draws the answers together and points to the chapters that build on them. In the printed and PDF editions, the sources for every chapter are listed together, chapter by chapter, at the back of the book.
The four running cases are illustrative products, used throughout the book so that one analysis can build on another. The table shows what each one illustrates:
| Case | The product | Why it is useful |
|---|---|---|
| The monitor | A wearable cardiac monitor with a companion application, from a US company | A manufacturer outside the Union entering the Union market, with the device hardware and its companion application each given its own risk class |
| The triage tool | AI-enabled triage software for urgent care, from a European company | How software is classed under Rule 11, the MDR classification rule for software, with the EU AI Act applying as well |
| The implant | A spinal implant from a European company holding a certificate under the former directive | Moving from a certificate under the former Medical Devices Directive, which the MDR replaced, and the rules for class III, the highest risk class, that apply to implants |
| The near-patient test | A cardiac troponin blood test used near the patient, from a Swiss company | The IVDR, a manufacturer outside the Union, and a risk class that depends on how the test is used |
The cases describe no real company or product. Where the analysis of a case depends on a judgement, the text marks it as "our reading", so that interpretation can always be told apart from rule.
How the book was researched#
Every statement of law or guidance in the book traces to a primary or official source, and a reader can check any of them in a few clicks. The citations at the end of each paragraph link to the official text, down to the article or page.
The book is desk research. Its sources are the consolidated texts of the regulations and the acts that amend them, and the implementing and delegated acts, the more detailed rules the Commission adopts under them. They also include guidance endorsed by the Medical Device Coordination Group (MDCG), the body of national authority representatives that agrees guidance on the regulations. The rest are publications of the Commission, the European Court of Auditors, national authorities, and payers.
Before a statement entered a chapter, its source was retrieved and the supporting wording quoted and checked word for word. The book uses no interviews and no figures from market research vendors.
Where two sources disagree, or where guidance goes further than the regulation it interprets, the chapter says so and cites both. Where no official figure exists, as is often the case for prices and market size, the chapter states that the figure is not published and does not estimate one.
Limits#
The book describes the law and guidance as they stood on the check date given in each chapter's sources. The regulations, their transition deadlines, and the guidance on them have been amended several times since adoption and may change again.
Guidance from the MDCG, the group of national authority representatives that agrees guidance on the regulations, is not legally binding. Only the Court of Justice of the European Union can give a binding interpretation of Union law. The book therefore reports what the guidance says and marks where it adds to the text of the regulations.
The book is general information. It is no substitute for legal, regulatory, or reimbursement advice on a specific product, nor for the decisions of a notified body or a competent authority, the national regulator responsible for devices. A notified body is the independent organisation that, where the law requires it, assesses a device before it can carry the CE mark.