# How large is the opportunity, and what can the published figures support?

## Introduction

A company planning European market entry needs a figure for its own opportunity, and needs to know how far that figure can be trusted. The figure sets the revenue target in the investment case and feeds the choice of which country to enter first. The headline usually quoted, roughly €170 billion for European medical technology, measures a whole industry and gives no route to one product's share, so it cannot carry a revenue target on its own.

This chapter explains what each kind of published figure measures and what it leaves out: trade association estimates, company-reported sales, official statistics, payer reports and vendor claims. It then sets out how a bottom-up estimate is built for one product. Such an estimate is assembled country by country, from counts of the patients the product could serve, how their care is paid for, and at what price.

It applies the method to four illustrative products used throughout the book. The monitor is a wearable cardiac monitor from a US company, and the triage tool is software enabled by artificial intelligence (AI) from a German company. The implant is a spinal implant system certified under the earlier Medical Devices Directive, Directive 93/42/EEC, and the near-patient test is a cardiac troponin test from a Swiss company.

The two EU laws that govern these products are cited in fixed versions. The Medical Device Regulation, Regulation (EU) 2017/745 (MDR), is stated as consolidated on 19 July 2026. The In Vitro Diagnostic Medical Device Regulation, Regulation (EU) 2017/746 (IVDR), is stated as consolidated on 10 January 2025. The sources were checked on 29 and 30 September 2026.

## In short

The €170 billion headline describes the whole industry, and on the authors' reading it cannot stand in for a count of one company's buyers. It is the 2024 estimate of MedTech Europe, the industry's European trade association, measured on manufacturers' sales without wholesale and retail margins. It covers the 27 Member States of the Union with Norway, Switzerland and the United Kingdom. Neither the report nor its data hub states whether it includes in vitro diagnostic medical devices (IVDs), tests run on samples such as blood, so on the authors' reading adding an IVD figure to it, or subtracting one, has no basis. ([Facts & Figures 2025, pp. 18 and 31][FF]; [data hub, Market page][HUB])

A diagnostics company can set its sales against the published IVD market for each country, provided it treats that market as an estimate. The European total of €13.3 billion for 2023 rests on estimates made country by country, built from company-reported sales in thirteen countries and from association estimates in the rest. ([IVD report 2025, pp. 4 and 13][IVD])

On the authors' reading, the public European database on medical devices, EUDAMED, can show who competes in a category and cannot show what anyone sold. The core data a manufacturer gives it for each device model are public, and none of them is a sales volume, a price or an installed base, meaning units already in use. ([MDR Art. 28(3); Annex VI, Part B][MDR]; [IVDR Art. 25; Annex VI, Part B][IVDR])

Official statistics supply the patient counts a bottom-up estimate starts from, with limits that matter for a hospital product. Health spending figures leave out what one care provider supplies to another as an input, so on the authors' reading they do not show separately the devices a hospital buys and uses inside a stay, and cannot size a hospital product. Hospital discharge figures count the principal diagnosis of each episode of care, so on the same reading a patient admitted twice counts twice. ([Eurostat, healthcare expenditure methodology][SE-SHA]; [Eurostat hlth_hosd metadata][META-HOSD])

In France, the fee per patient for reimbursed remote monitoring can fall as more patients are monitored. Assurance Maladie, the national health insurer, states that its amounts can be revised periodically according to the number of patients actively monitored at the same fee level for the same condition, and they fall as that number rises. On the authors' reading, the upper figure in the illustrative French range for the book's wearable heart monitor is therefore the more exposed to revision. ([ameli.fr, télésurveillance][AMELI])

## 1. What can a sizing model count?

A medical device is defined by the medical purpose its manufacturer intends. An IVD is a device the manufacturer intends for examining specimens from the human body in vitro, solely or principally to give information on one of six listed matters, such as a pathological state. Qualification and class are set out in chapter 1, *Is it a medical device, which class, and who is responsible?*. ([MDR Art. 2(1)][MDR]; [IVDR Art. 2(2)][IVDR])

The intended purpose is what the label, the instructions for use, promotional and sales material, and the clinical or performance evaluation say the device is for. Our reading, meaning the authors' interpretation and not the instrument's words, is that it also defines the patients a model can count. A model that counts patients outside it sizes a product the manufacturer has not declared. ([MDR Art. 2(12)][MDR]; [IVDR Art. 2(12)][IVDR])

A sales forecast counts supply. Making available on the market is any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity. Supply counts whether it is paid for or free of charge, and the IVDR excludes devices for performance study in the same way as the MDR excludes investigational devices. ([MDR Art. 2(27)][MDR]; [IVDR Art. 2(20)][IVDR])

Placing on the market is the first such supply in the Union. Our reading is that a revenue model counts the paid part of that supply, so free evaluation units belong in the cost plan. ([MDR Art. 2(28)][MDR]; [IVDR Art. 2(21)][IVDR])

## 2. What do the published market totals measure?

The regulations are law, and the published market figures come from five other kinds of source: trade association estimates, company-reported sales, official statistics, payer reports and vendor claims. Each carries a different weight.

### The €170 billion headline

MedTech Europe, the European trade association for the industry, publishes *Facts & Figures 2025*. It estimates the European medical technology market at roughly €170 billion in 2024, and calls Europe the second-largest medical device market in the world. It names the five biggest markets as Germany, France, the United Kingdom, Italy and Spain. ([Facts & Figures 2025, p. 18][FF])

Our reading is that a published total measures a whole industry, so it cannot stand in for a count of one company's buyers.

The report's sentence giving the figure cites two references. Reference 10 is Fitch Solutions, *Worldwide Medical Devices Market Factbook 2024*, dated 2025. Reference 11 is International Trade Centre statistics with MedTech Europe calculations, also dated 2025. The reference list gives no web address or access route for either. ([Facts & Figures 2025, pp. 18 and 32][FF])

MedTech Europe's online data hub gives the same €170 billion, with two sources. One is MedTech Europe calculations based on the Fitch factbook, on manufacturer prices, for "medical technology excluding IVD". The other is MedTech Europe's own *European IVD Market Statistics Report 2022*. The figure is therefore MedTech Europe's estimate. ([data hub, Market page][HUB])

The market chapter of the report is based on manufacturers' sales, without margins such as value added in wholesaling and retailing, transport costs and "some taxes included in the final price". Our reading is that a hospital pays more for the same device, so the figure is smaller than what buyers spend. ([Facts & Figures 2025, p. 31][FF])

Europe there means the EU27, the 27 Member States of the Union, with Norway, Switzerland and the United Kingdom, unless the report says otherwise. ([Facts & Figures 2025, p. 31][FF])

The regulations' definitions speak of the Union market. The Medical Device Coordination Group (MDCG) is composed of representatives of all Member States and chaired by a representative of the Commission. Its guidance interprets the Union market as the territories of the Member States, and extends it through the European Economic Area to Norway, Iceland and Liechtenstein, and through the Customs Union Agreement to Turkey. ([MDR Art. 2(27)][MDR]; [MDCG 2022-16, cover page and p. 2][MDCG-2022-16])

Switzerland and the United Kingdom are not named in that reading. The guidance states that its views are not legally binding and that only the Court of Justice of the European Union can give binding interpretations of Union law. ([MDCG 2022-16, cover page][MDCG-2022-16])

Neither the report nor the hub states whether the €170 billion includes IVDs. The report calls it the "medical technology market", and the hub sets a series excluding IVDs beside the IVD report as its two sources. Our reading is that the pairing suggests the total includes IVDs. ([data hub, Market page][HUB])

The report itself cites the figure to references 10 and 11, and its reference for IVDs is number 9. The hub and the report therefore point in opposite directions on whether the total includes IVDs, so our reading is that adding an IVD figure to the total, or subtracting one from it, has no basis. ([Facts & Figures 2025, p. 32][FF])

### The split between countries

Graph 6 of *Facts & Figures 2025* splits the 2024 European medical device market by country, on manufacturer prices. Germany has 25.2%, France 12.8%, the United Kingdom 11.9%, Italy 11.7% and Spain 6.1%. The Netherlands has 5.9%, Switzerland 3.8%, Belgium 3.5%, Austria 3.2%, Poland 2.7%, and all others together 13.2%. The graph states no source reference, so its citable source is MedTech Europe itself. ([Facts & Figures 2025, Graph 6, p. 19][FF])

Computed by the authors from Graph 6: the five largest add to 67.7% (25.2 + 12.8 + 11.9 + 11.7 + 6.1). Germany's share is 4.1 times Spain's (25.2 / 6.1), and the 13.2% under "others" is slightly more than France's 12.8%.

**Figure 3.1. Five countries hold 67.7% of the published device market, 2024, manufacturer prices.**

![Figure 3.1: the European medical device market by country](figures/figure-3-1-device-market-by-country.svg)



Our reading is that Germany and Spain are markets of different size, though both sit in the top five. A plan that gives each of the five the same headcount and the same first-year ramp treats a market of 25.2% and a market of 6.1% alike.

### The IVD market

MedTech Europe's *European IVD Market Statistics Report 2025* puts 2023 IVD market revenues at €13.3 billion, down 20.2% on 2022. The figure covers the EU27, the European Free Trade Association (EFTA) countries and the United Kingdom. Its table gives €13,315 million for 2023 and €16,685 million for 2022. ([IVD report 2025, pp. 4 and 5][IVD])

The report says its results rest on estimates made country by country. Thirteen countries take part in the Global Diagnostic Market Statistics (GDMS) programme: Austria, Belgium, the Czech Republic, France, Germany, Italy, the Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland and the United Kingdom. For the others, MedTech Europe's national association members and its Market Research Committee estimated the market. ([IVD report 2025, p. 13][IVD])

In GDMS, participating companies report invoiced sales of reagents, instruments and consumables to an independent auditor. MedTech Europe states that GDMS covers more than 85% of the market "in major countries", and does not name them. Rapid tests bought through national government arrangements from companies outside the programme might not all be captured. ([IVD report 2025, p. 13][IVD])

Two national figures are partial. France covers the central laboratory IVD market and excludes diabetes. The United Kingdom figure is GDMS company sales plus the glucose test strip sales that National Health Service England publishes, adjusted to the whole of the United Kingdom. ([IVD report 2025, p. 5][IVD])

A diagnostics company can therefore express its sales as a share of a published market figure for each country. That market figure is an estimate in every country: built from company-reported sales in thirteen, from association estimates in the rest, partial for France and adjusted for the United Kingdom.

The report's table gives a value for each country. Computed by the authors: Germany holds 17.7% of the 2023 market (2,351 / 13,315). ([IVD report 2025, p. 5][IVD])

### The pandemic years

MedTech Europe reports that the European IVD market grew at around 0 to 2% a year from 2010 to 2019, reaching €11.1 billion in 2019. Testing for coronavirus disease 2019 (COVID-19) then lifted revenue by 29% in 2020 and 41% in 2021, and the market fell back in 2022 and 2023. *Facts & Figures* also attributes the 2020 to 2021 spike to pandemic demand. ([IVD report 2025, p. 4][IVD]; [Facts & Figures 2025, p. 23][FF])

The report's chart prints a growth rate for each year from 2013 to 2023: −0.5%, −0.3%, 1.5%, 0.2%, 1.9%, 1.2%, 0.4%, 29.1%, 41.2%, −19.3% and −20.2%. ([IVD report 2025, p. 4][IVD])

**Figure 3.2. European IVD market growth rates, 2013 to 2023: seven years within two points of zero, two pandemic years up and two years down.**

![Figure 3.2: European IVD market growth rates, 2013 to 2023](figures/figure-3-2-ivd-growth-rates-2013-2023.svg)



Computed by the authors: the 2023 market of €13.3 billion is about 1.2 times the 2019 level of €11.1 billion (13.3 / 11.1), so about a fifth above it. The ratio is approximate, because the report converts at 2023 exchange rates and does not say at what rate the 2019 figure is expressed. ([IVD report 2025, p. 5][IVD])

Also computed: compounding the printed rates gives about 1.9% a year over 2013 to 2023 and 2.1% over 2014 to 2023. The note to figure 3.2 shows the product and why a simple average of the rates is higher.

Our reading is that a growth claim for diagnostics should state its window and its method, and that a window starting in 2020 or 2021 describes the pandemic.

Germany's IVD industry association, quoted in the report, says coronavirus diagnostics were 65% of German IVD sales at the 2021 peak. By its account, the German market's 35% fall in 2023 becomes 4.3% after adjusting for coronavirus testing. ([IVD report 2025, p. 10][IVD])

For the device market as a whole, MedTech Europe puts yearly growth since 2010 between 2.4% (2017) and 9.3% (2015), citing the Fitch factbook. It adds that the pandemic postponed elective surgery in 2020 and raised sales of ventilators and consumables. A single device category's own figures for 2020 to 2023 show whether the pandemic affected it. ([Facts & Figures 2025, pp. 22 and 24][FF])

## 3. Which other figures describe the industry without sizing a product?

Investors and advisers quote several other European figures.

| Figure | What it measures | Sizes a product? |
|---|---|---|
| About 10% of gross domestic product (GDP) spent on healthcare, around 7.7% of that on medical technologies: 7.1% devices including imaging, 0.6% IVDs | MedTech Europe's calculation, with no reference year | No |
| Eurostat HC.5.2, therapeutic appliances and other medical goods: €70,782.98 million for the EU27 in 2023, €157.77 a person, 4.12% of current health expenditure, provisional | Medical durable goods such as orthopaedic appliances, prostheses and implants | No; context only, for the reason below |
| Device market growth, average over the past ten years: 6.0% in *Facts & Figures*, 5.6% on the data hub read on 29 September 2026 | A Fitch-based series; neither states which ten years, and the hub is updated as data arrive | No |
| IVD market growth, average: 4.3% with no period in *Facts & Figures*, 3.6% over the past decade on the hub | The hub cites the 2022 IVD report for its figure, the only IVD source in *Facts & Figures*' reference list | No; the 2025 report prints a rate for each year instead |
| Company counts, such as more than 38,000 medical technology companies, and trade balances, such as a device trade surplus of €5 billion in 2024 | The industry itself: how many companies it has, and where devices are made and bought | No |

([Facts & Figures 2025, pp. 16, 17, 22, 23, 25 and 32][FF]; [data hub, Market page][HUB]; [data hub, Introduction page][HUB-INTRO]; [Eurostat hlth_sha11_hc][SHA-HC]; [Eurostat SHA 2011 metadata][META-SHA])

The 7.7% and the 4.12% measure different things over different geographies, and no source reconciles them.

HC.5.2 records these goods where the function and the mode of provision are not specified, and Eurostat defines in-patient and out-patient care as functions of their own. Our reading is that a device supplied within a hospital stay or visit may be recorded under that care function, outside HC.5.2. Eurostat's metadata does not say how a given product is recorded, so HC.5.2 cannot set an upper limit on spending for one product. ([Eurostat SHA 2011 metadata][META-SHA])

## 4. Why do commercial market reports give larger figures?

Commercial research vendors publish European market sizes on web pages that are undated and change without notice. On 29 September 2026, three vendor pages gave the European IVD market for 2025 in US dollars (USD): USD 28.69 billion, USD 28.99 billion and USD 31.43 billion. ([vendor A][V-IMARC-IVD]; [vendor B][V-EMR]; [vendor C][V-MM])

Computed by the authors: MedTech Europe's €13,315 million for 2023, at the European Central Bank's (ECB) 2023 average of 1.0813 dollars per euro, is about USD 14.4 billion. The vendor figures are 2.0 to 2.2 times that. ([IVD report 2025, p. 5][IVD]; [ECB][ECB])

The two sets of figures are for different years. For growth alone to close the gap to the lowest vendor figure, the market would need to grow by about 41% a year over 2023 to 2025 (1.41 × 1.41 = 1.99), whereas MedTech Europe reports falls in 2022 and 2023.

None of the vendor pages states whether its geography or product scope matches MedTech Europe's, so our reading is that they measure something other than company-reported manufacturer sales. Two of them count software or services as IVD, which GDMS's reagents, instruments and consumables do not name. Our reading is that this difference in scope probably explains part of the gap, by an amount no source gives. ([vendor A][V-IMARC-IVD]; [vendor B][V-EMR])

## 5. What does EUDAMED show?

EUDAMED is the European database on medical devices, set up by the Commission. One of its purposes is to inform the public about devices placed on the market. It includes the UDI database, the regulations' name for the database of unique device identifiers (UDIs). ([MDR Art. 33(1)][MDR]; [IVDR Art. 30(1), (2)][IVDR])

The core data elements a manufacturer gives that database with each device identifier are public free of charge. They include the manufacturer's name and address, the nomenclature code, the risk class, and the device's market status. None of the 24 items under the MDR, or the 21 under the IVDR, is a sales volume, a price or an installed base. ([MDR Art. 28(3); Annex VI, Part B][MDR]; [IVDR Art. 25; Annex VI, Part B][IVDR])

Our reading is that the public side of EUDAMED counts competitors and their devices, which is useful for mapping a category, and says nothing about what anyone sold. Registration and UDI are covered in chapter 9, *Who registers the company, its partners and each device, and by when?*.

## 6. What do official statistics count?

Bottom-up sizing starts from counts that someone other than a vendor has made. Eurostat, the statistical office of the Union, publishes counts of population, of health spending by function, and of hospital activity.

**Population.** Eurostat's figure is the population on 1 January, and the recommended definition is the usually resident population. On 1 January 2025 the EU27 had 450,646,971 people, estimated and provisional. ([Eurostat demo_pop metadata][META-POP]; [Eurostat demo_pjan][POP])

Eurostat's dataset has no United Kingdom line from 2021 to 2025, and nor does its health expenditure dataset, so United Kingdom counts come from a United Kingdom official source.

**Spending.** Eurostat's health spending figures count the care goods and services people finally receive, and leave out what one care provider supplies to another as an input. Our reading is that they do not show separately the devices a hospital buys and uses inside a stay, so they cannot size a hospital product. ([Eurostat, healthcare expenditure methodology][SE-SHA])

For the functions that have an EU27 line, 2023 is the latest year on which the countries and the EU27 can be set side by side. ([Eurostat hlth_sha11_hc][SHA-HC])

**Hospital episodes.** A hospital discharge is the formal release of a patient after an episode of care. The reasons include completed treatment, transfer to another institution and death, and healthy newborns are excluded. Discharges by diagnosis count the principal diagnosis. ([Eurostat hlth_hosd metadata][META-HOSD])

Our reading is that a patient admitted twice in a year counts twice, so discharges count episodes, which is a different number from patients. In some countries, data may not be available for a subgroup of institutions, such as private hospitals, and the underlying administrative sources may differ in coverage and comparability. ([Eurostat hlth_hosd metadata][META-HOSD])

The current table, `hlth_tinpat1`, covers in-patients for 2022 and 2023. Day cases are not in it. Its EU27 lines stop at broad disease groups, such as diseases of the circulatory system, so an EU total for a single diagnosis has to be summed from country lines. ([Eurostat hlth_tinpat1][TINPAT])

## 7. What do payers' own figures show?

Where a national payer runs a route for digital products, its own reports count what it paid. The counts change, so read the payer's current page, cited in the sources, before relying on one. The route itself is in chapter 13, *Which national route does the product take, and who pays at the end?*.

### Germany

DiGA (digitale Gesundheitsanwendungen) are digital health applications paid for by statutory health insurance (gesetzliche Krankenversicherung, GKV). The GKV-Spitzenverband, the national association of the statutory funds, describes them as medical devices of class I or IIa, and since the Digital Act of 2024 also class IIb. Insured people get them on prescription or by direct approval from their fund. ([GKV-Spitzenverband, DiGA focus page][GKV])

The payer states that the manufacturer's own price applies for the first year after admission, and the amount agreed with the GKV-Spitzenverband after that. A price framework agreement between the payer and the manufacturers' associations sets maximum amounts for groups of comparable DiGA, which limit first-year reimbursement. A sizing model for Germany therefore uses two prices: the manufacturer's price in the first year and the agreed amount from then on. ([GKV-Spitzenverband, DiGA focus page][GKV])

The payer's report for 2025 counts about €400 million of statutory spending on DiGA from September 2020 to the end of 2025, of which over €170 million fell in 2025. Its predecessor gave €234 million for September 2020 to December 2024, of which €110 million fell in 2024. ([DiGA-Bericht 2025][DIGA25]; [DiGA-Bericht 2024][DIGA24])

Each report's headline figure is cumulative. Computed by the authors: yearly spending grew by more than half from 2024 to 2025 (over 170 / 110 = 1.545).

In its summary, the report sets an average manufacturer price beside a lower average negotiated price. The summary does not state the basis of these averages. The report's price table is for a first prescription and 90 days of use, so none of them is a price per patient per year. The report is the payer's own count, and the payer argues for tighter rules. ([DiGA-Bericht 2025][DIGA25]; [GKV-Spitzenverband, DiGA focus page][GKV])

### France

Assurance Maladie, the national health insurer, pays reimbursed remote monitoring through two flat fees. The operator fee pays the health professional, and the technical fee pays the company operating the digital medical device. For the same patient, indication and period, neither can be billed without the other. ([ameli.fr, télésurveillance][AMELI])

The technical fee has four levels, set by the ministerial order, or arrêté, of 16 May 2023. The level follows the organisational or clinical interest assessed by the CNEDiMTS, the Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé. It is the committee that evaluates the company's file. G_NIUS, the ministerial digital health delegation's guidance site, gives the current base rate per patient per month for each level, including tax. ([ameli.fr, télésurveillance][AMELI]; [G_NIUS, PECAN][GNIUS-PECAN]; [G_NIUS, remote monitoring][GNIUS-TLS])

Assurance Maladie states that the amounts can be revised periodically according to the number of patients actively monitored at the same fee level for the same condition. They fall as that number rises. G_NIUS adds that this active file includes all manufacturers' patients in the indication. ([ameli.fr, télésurveillance][AMELI]; [G_NIUS, remote monitoring][GNIUS-TLS])

The fee covers a 30-day period and is billed after each period of actual use. Assurance Maladie covers 60% of the fee for patients under the general scheme and 100% for patients exempt from the co-payment. The rest is billed to the patient's complementary insurer under a third-party payment agreement, or settled with the patient. ([ameli.fr, télésurveillance][AMELI])

PECAN (prise en charge anticipée numérique), which G_NIUS calls advance digital care, gives one year of exceptional coverage while the company completes its evidence. For remote monitoring it is not renewable. Assurance Maladie states that, for remote monitoring, PECAN is open only to conditions with a favourable opinion of the Haute Autorité de santé (HAS) published by ministerial order. ([G_NIUS, PECAN][GNIUS-PECAN]; [ameli.fr, télésurveillance][AMELI])

### Belgium

INAMI (Institut national d'assurance maladie-invalidité), the national health insurance institute, reimburses certain medical mobile apps under conditions and a procedure it publishes. It asks applicants to attach a literature review and an assessment of financial impact. Our reading is that the assessment is a sizing exercise in its own right. ([INAMI, medical mobile apps][INAMI-APPS])

INAMI also reimburses hospitals holding a convention with it for remote monitoring of patients recently hospitalised for heart failure, or whose hospitalisation heart failure complicated. The convention pays the hospital, and a separate flat fee pays the patient's general practitioner. The page gives no amount for either, and gives the convention's fixed term. ([INAMI, heart failure remote monitoring][INAMI-HF])

## 8. How the answer is reached

The estimate is built one country at a time, and each step takes the previous answer as its input.

1. **The intended purpose defines which patients a model may count** (section 1). Where the sources checked give no payment route or rate in a target country, that country's route has not yet been researched. A country outside the target list whose payment route is close to the intended purpose is a conditional option for the order in which countries are entered.
2. **The unit of sale and the buyer come next.** One sale may be a device, a test, a patient-month of monitoring or a licence. The payer may be a statutory payer, a hospital, a laboratory or the patient, and through a distributor the company's revenue is the price the distributor pays. Our observation, meaning what the authors have seen in practice and not a sourced finding, is that sizing errors often start here, when a model counts patients and the buyer pays per site.
3. **Context figures carry a full citation**: the document, its date, the page and any onward reference, and for a live web page the date it was read. A source line that names only the publisher cannot be checked. For the headline, that is MedTech Europe, *Facts & Figures 2025*, reissue of 5 September 2025, page 18, citing references 10 and 11. ([Facts & Figures 2025, pp. 18 and 32][FF])
4. **Each figure is recorded with its kind, geography and price basis**, the kind being trade association estimate, company-reported sales, official statistic, payer report or vendor claim (sections 2 to 7).
5. **The eligible group comes from official data**: the population and the hospital or spending line nearest the intended purpose, with its dataset code, year, update date and any status flag. The model records whether a count is of patients or of episodes, and whether it sets an upper limit on the group or only gives a reference point for its size. ([Eurostat demo_pjan][POP]; [Eurostat hlth_tinpat1][TINPAT]; [Eurostat hlth_sha11_hc][SHA-HC])
6. **Each count's limits are recorded**, such as a country that cannot report private hospitals, a flag such as "definition differs", or a missing country. Where the count does not exist, it is a gap, named with the source that would close it. ([Eurostat hlth_hosd metadata][META-HOSD]; [Eurostat hlth_sha11_hc][SHA-HC])
7. **The rate is the payer's, where a payer publishes one**, as it stands on the payer's current page on the day the model is built. Where no rate is published, the price comes from buyers and distributors. ([ameli.fr, télésurveillance][AMELI]; [G_NIUS, remote monitoring][GNIUS-TLS])
8. **Adoption is an assumption**, labelled illustrative, with a low and a high value and the evidence that would change it.
9. **The range is a labelled computation**: the eligible group times the adoption share, the units per patient and the rate, each input with its source.
10. **The result is cross-checked against the top-down figures**: for an IVD, the country's IVD market, and for a device, the nearest published line shown to include the product, where one exists. Our reading is that a single product will usually be a small share of a broad line, and a large share should first be checked for an error in scope or in the unit of sale. ([IVD report 2025, p. 5][IVD])
11. **The model is updated when each source releases new data.** Eurostat's voluntary release date for health expenditure is 15 November of the second year after the reference year, and hospital discharge data are normally released in December. The current discharge table was last updated on 12 March 2026, and the latest DiGA report covers the period to 31 December 2025. ([Eurostat SHA 2011 metadata][META-SHA]; [Eurostat hlth_hosd metadata][META-HOSD]; [Eurostat hlth_tinpat1][TINPAT]; [DiGA-Bericht 2025][DIGA25])

## 9. The four running cases

### The monitor: a wearable cardiac monitor from a US company

The monitor is a wearable cardiac monitor with a companion application. Chapter 1 gives its intended purpose as recording the wearer's heart rhythm continuously for later review by a clinician. As an illustrative assumption of this book, the monitor launches in Germany and the Netherlands together, and France later.

On chapter 1's reading, the hardware is class IIa under Rule 10. The application is classified separately. It is class IIa if it only records for later review, and class IIb if it analyses the rhythm and its output is intended to guide a physician's diagnosis. The planning assumption is that it records only.

| Country | Payment route in the sources checked | Eligible-group anchor, 2023 in-patient discharges | Rate or price |
|---|---|---|---|
| Germany | Physician fee schedule, the Einheitlicher Bewertungsmaßstab (EBM); DiGA, a question for the application | 481,741, conduction disorders and cardiac arrhythmias | Physician fees for long-term electrocardiogram (ECG) recording (fee schedule item, or Gebührenordnungsposition, GOP 03322) and its analysis (GOP 03241); no device price |
| Netherlands | Nederlandse Zorgautoriteit (NZa) add-on "Telemonitoring" (039133) | 32,713, same diagnosis group | A maximum tariff the hospital may bill; no device price |
| France | Remote monitoring payment mechanism; no line for this indication identified | 193,400, same diagnosis group | The illustrative calculation below |
| Belgium | Heart failure convention; on our reading, rhythm recording falls outside it | 12,170, heart failure | No amount published |

([KBV, EBM][EBM]; [NZa][NZA-TM]; [Eurostat hlth_tinpat1][TINPAT]; [ameli.fr, télésurveillance][AMELI]; [INAMI, heart failure remote monitoring][INAMI-HF])

Germany and the Netherlands therefore have a fee for the service and no price for the device, and which route the monitor takes in each is a question for chapter 13. The sources checked do not include German hospital tariffs.

The discharge counts give a reference point for the size of the group and no upper limit on it, because people monitored as outpatients do not appear in the table. France and Belgium are options beside the launch countries, each conditional on a payment route that covers the monitor, and chapter 2, *Which market should come first, and on what evidence?*, decides the order.

**The German application.** The payer describes DiGA as medical devices based on digital technologies, and whether the companion application could be one is a route question for chapter 13. Statutory spending on all DiGA was over €170 million in 2025, across every DiGA dispensed that year. Our reading is that one application's revenue is its prescriptions times its price in each of the two price periods, so the scheme total is context only. ([GKV-Spitzenverband, DiGA focus page][GKV]; [DiGA-Bericht 2025][DIGA25])

The payer states that a class IIb DiGA must show a positive care effect at admission and cannot be listed on trial, as lower-class DiGA can. On chapter 1's classes, the application is class IIa while it only records, and an algorithm that analyses the rhythm would move it to class IIb. Our reading is that whether the application analyses the rhythm therefore also decides whether a German model can assume a trial listing. ([GKV-Spitzenverband, DiGA focus page][GKV])

**The Belgian route.** The convention covers patients in class II, III or IV of the New York Heart Association (NYHA) scale, after an acute episode has stabilised, and pays the hospital. Our reading is that an intended purpose of recording heart rhythm does not cover heart failure monitoring. Reaching this route would mean widening the intended purpose, which chapter 1 shows can move the class. ([INAMI, heart failure remote monitoring][INAMI-HF])

Suppose, as an illustrative step, that the company did widen it. INAMI states that about 2 to 3% of the Belgian population has chronic heart failure, and gives no source or year. Computed by the authors: on Eurostat's 11,883,495 people on 1 January 2025, that is 237,670 to 356,505 people. The estimate is 19.5 to 29.3 times the 12,170 discharges (237,670 / 12,170 and 356,505 / 12,170). ([INAMI, heart failure remote monitoring][INAMI-HF]; [Eurostat demo_pjan][POP]; [Eurostat hlth_tinpat1][TINPAT])

**Figure 3.3. Two counts for the Belgian heart failure group, and the group the payment route uses.**

![Figure 3.3: which count sizes the monitor](figures/figure-3-3-which-count-sizes-the-monitor.svg)



Our reading is that the discharge count is the closer reference point for the group the convention covers, and it is imperfect in both directions. It counts a patient admitted twice as two episodes, and it leaves out patients whose heart failure complicated an admission for something else. Neither count measures the convention's group.

**The French route.** In France, the unit of sale is a patient-month, billed by the company operating the device.

Assurance Maladie's page says devices are entered on the national list of medical remote monitoring activities by brand name or under a generic line, and does not reproduce that list. These sources cannot show whether a line covers the monitor's indication or the fee level it would carry, and they do not cover physician-billed acts or hospital purchasing. ([ameli.fr, télésurveillance][AMELI])

The Classification commune des actes médicaux (CCAM), version 75 of 1 March 2024, lists a physician act for a 24-hour Holter ECG (DEQP005). That act is not a fee for a remote monitoring line. ([CNAM][CCAM])

The calculation rests on three illustrative assumptions. A remote monitoring line exists. The company has 500 to 2,000 patients billed in every 30-day period of its first full year. The base fee is €50 to €90 a patient a month.

Evidence on the uptake of comparable lines, or the payer's own active-patient counts, would move the range, and the current amount for the assessed level from G_NIUS would replace the assumed fee. ([G_NIUS, remote monitoring][GNIUS-TLS])

Computed by the authors, if a line exists at these illustrative fees:

- Result: 500 patients × 12 billing periods × €50 is €300,000 a year, and 2,000 × 12 × €90 is €2,160,000. A year holds about 12.2 thirty-day periods (365 / 30), so twelve slightly understates it.
- Tax and co-payment: the payer states its rates including tax, so the company's net revenue is lower by any value added tax (VAT) due. The share of patients at each of the co-payment rates set out in section 7 decides how much the company collects outside Assurance Maladie.
- Sensitivity: adoption moves the result by a factor of 4 (2,000 / 500), and the fee by 1.8 (90 / 50).
- Cross-check: no published French spending line is shown to include remote monitoring fees, and HC.5.2 cannot set an upper limit on spending for one product, for the reason given in section 3, so no top-down cross-check exists.
- Plausibility, a separate check: 500 to 2,000 patients is 0.26% to 1.03% of the 193,400 arrhythmia discharges (500 / 193,400 and 2,000 / 193,400).

Our reading is that the upper figure is the more exposed to revision, because the fee falls as patients in the indication rise across all manufacturers. On the same reading, the billing rules on Assurance Maladie's page for implanted cardiac devices do not apply to a wearable.

**Carrying a rate across countries.** Heart failure discharges, computed by the authors from Eurostat's 2023 discharges and 2025 population, run at 5.6 per 1,000 people in Germany (468,864 / 83,577,140) against 1.1 in Spain (54,428 / 49,128,297). Neither Eurostat table explains the difference, and discharges do not measure prevalence, so a rate carried from one country to another needs a source that explains the gap. ([Eurostat hlth_tinpat1][TINPAT]; [Eurostat demo_pjan][POP])

The evidence still missing includes a device price in Germany and the Netherlands, German hospital tariffs, and whether the US company or its importer would be the operator billing the French technical fee.

In France the missing evidence also includes the current list of remote monitoring lines, physician-billed and hospital routes for rhythm recording, the current base rate for the assessed level and the co-payment mix. In Belgium it includes the convention amount.

### The triage tool: AI-enabled software from a German company

The triage tool is AI-enabled software from a company whose home Member State, Germany, is also its first market. Chapter 1's illustrative intended purpose places it with triage nurses in adult urgent care centres. Classes IIa to III are all arguable under Rule 11, and chapter 1 plans it as class IIb.

No listed source counts the decisions it would support. Site counts exist for three countries: the Netherlands, 79 hospital locations with a basic emergency department; France, 719 emergency reception points in 2023; and Belgium, 117 recognised emergency services. They count emergency departments, and the sources listed hold no count of urgent care centres and none for Germany, the first market, or Austria. ([VZinfo][VZINFO]; [DREES][DREES]; [FPS Health][BE-FOD])

Vendor figures for European digital health cannot fill that gap. Three vendor pages give 2025 values of USD 96.68 billion, USD 100.17 billion and USD 130.37 billion, with growth rates from 10.27% to 22.5% a year over different periods. One page's segment list includes medical wearables, electronic health records, medical apps and analytics, so its "digital health" is wider than regulated software. ([vendor D][V-MORDOR]; [vendor E][V-NOVA]; [vendor A][V-IMARC-DH])

The MedTech Europe publications and Eurostat datasets in the sources give no European digital health market value (checked 29 September 2026). A European Commission study of 17 March 2026 projects the EU digital health market at €11 billion in 2023 and €61.2 billion by 2035. That figure uses the study's own digital health scope. None of the sources explains the gap to the vendor values. ([European Commission][EC-DH])

Our reading is that the unit is a licence per site, bought by the operator of the urgent care centre. The first count to build is then the number of urgent care centres in each target country, and the price comes from buyers. No source gives the eligible group, and the model cannot be completed until evidence from customers is available.

### The implant: a spinal implant from a European company with a directive certificate

The implant is a spinal implant system from a Union manufacturer: an interbody cage with screws, plates, hooks and rods. Chapter 1 classes it by component. The cage is class III, screws and plates are class IIb, hooks are class IIb on MDCG 2021-24 rev.1's reading, and rods, wires and pins are open.

As an illustrative assumption of this book, the implant is certified under Directive 93/42/EEC and is seeking its first certificate under the MDR. The starting point is its own sales history, since it already sells, and the public sources add little.

Eurostat's surgical procedures table, `hlth_co_proc3`, has 20 procedure groups, among them cataract surgery and hip replacement, and none is a spinal procedure. Countries code procedures in their own classifications, which cannot always be converted without losing meaning. No source in this chapter gives spinal procedure volumes by country. ([Eurostat hlth_co_proc3][PROC]; [Eurostat hlth_res metadata][META-RES])

Eurostat counts discharges for spinal diagnoses by principal diagnosis. Our reading is that such a count includes admissions with no surgery, so it cannot count implant procedures. ([Eurostat hlth_tinpat1][TINPAT])

As an illustrative assumption, the implant is sold in Germany and Italy under its directive certificate. Computed by the authors: Germany's count for deforming dorsopathies and spondylopathies is 8.7 times Italy's (242,610 / 27,900), with a population 1.42 times as large (83,577,140 / 58,943,464). Eurostat's tables do not explain the gap, and a model extrapolating from one country's diagnoses to another would carry it into the forecast.

Eurostat's HC.5.2 line lists implants among its goods, and the limit in section 3 applies, since an implant fitted during a hospital stay may be recorded under in-patient care instead. Germany's €21,235 million on the line in 2023 is therefore context only, and no top-down cross-check is available until a source for procedure or implant volumes is found. ([Eurostat SHA 2011 metadata][META-SHA]; [Eurostat hlth_sha11_hc][SHA-HC])

The public sources do not identify the buyer, so the buyer comes from the company's own sales records, as do its sales by country.

### The near-patient test: a cardiac troponin test from a Swiss company

The near-patient test is a cardiac troponin blood test used near the patient in hospital emergency departments, read on a point-of-care analyser the same company supplies. Its Swiss manufacturer has no Union entity and already sells it into several Member States through distributors.

As an illustrative assumption of this book, the test was placed on the Union market under a declaration of conformity drawn up under Directive 98/79/EC, with no notified body. Chapter 2 sets out the conditions on which it may stay.

**Unit and buyer.** One sale is a test. Chapter 1 records the Union distributors as importers and hospital suppliers as distributors, so the company's buyer is the importing distributor and the hospital is the end buyer. The company's revenue is the price the importer pays.

Eurostat's laboratory line, HC.4.1, covers ancillary services the patient consumes directly and that are not an integral part of a care package. Our reading is that laboratory work inside a hospital care package falls outside it, so that line cannot size this product. ([Eurostat SHA 2011 metadata][META-SHA])

**Context.** Suppose, as an illustrative assumption, that the distributors sell into Germany, the Netherlands, Belgium and Austria. MedTech Europe's IVD report gives the 2023 IVD market in each, against which the company's sales can be set: Germany €2,351 million, the Netherlands €628 million, Belgium €379 million and Austria €357 million. The company's home market, Switzerland, is €562 million, the highest per person at €64. ([IVD report 2025, p. 5][IVD])

**The eligible group is missing.** The count the model needs is emergency department patients tested for cardiac troponin, and no listed source gives it. France's OSCOUR network (Organisation de la surveillance coordonnée des urgences) published a bulletin on 3 March 2026. It reports 13,121 chest pain attendances in week 09 of 2026, which counts attendances for a single week and does not count troponin tests. ([Santé publique France][OSCOUR])

Eurostat's acute myocardial infarction discharges are a different quantity: Germany 206,181, the Netherlands 30,027, Belgium 16,190 and Austria 15,421 in 2023. They count admissions with infarction as the principal diagnosis, so the patients in whom the test ruled infarction out are not in them. ([Eurostat hlth_tinpat1][TINPAT])

**The intended purpose changes the count.** Chapter 1 sets out two intended purposes, serial and single measurement, and plans both as class C until a notified body confirms otherwise. Our reading is that serial measurement means more than one test per patient, so the serial purpose multiplies the unit count where the single one would not.

The number of tests per patient, and the price per test, come from buyers. In Germany, the EBM pays a fee for troponin on a prefabricated reagent carrier (GOP 32150), and it covers that service only. ([KBV, EBM][EBM])

**What one association reports.** Spain's IVD industry association, quoted in the report, says point of care testing has developed below expectations. The main reason it gives is the lack of reimbursement outside hospitals and primary care centres. It adds that the number of tests is growing slightly while prices are declining or flat. ([IVD report 2025, p. 11][IVD])

Our reading is that this is one association's view of one country, and that it still directs the model to hospital budgets, which is where this test is used. The test volumes by country, the tests per patient and the importer's price per test remain open, and the top-down cross-check is each country's IVD market.

## 10. When specialist help is worth paying for

- **An investor asks for the source behind the headline.** The headline rests on a Fitch factbook, reference 10 in MedTech Europe's list, and access to it comes from its publisher. ([Facts & Figures 2025, p. 32][FF])
- **The eligible group sits inside a hospital care package.** Eurostat's laboratory line leaves out work inside a care package, and a health economist can advise how to count it. ([Eurostat SHA 2011 metadata][META-SHA])
- **Countries are compared on Eurostat data.** Each country's methodological annex sets out its comparability issues, and a statistician reads them faster. ([Eurostat SHA 2011 metadata][META-SHA])
- **A payer asks for a financial impact assessment.** INAMI asks for one with an application for reimbursement, and chapter 14 covers the model. ([INAMI, medical mobile apps][INAMI-APPS])
- **The fee level or listing decides the case.** In France the CNEDiMTS assessment sets the technical fee level, and a national market access adviser knows which levels comparable products reached. ([ameli.fr, télésurveillance][AMELI])

## Conclusion

A revenue estimate for one product is built from the bottom up, one country at a time, and each step takes the previous one as its input. The intended purpose, meaning what the manufacturer declares the device is for, defines which patients a model may count. The unit of sale and the buyer decide what one sale is and who pays. The authors' observation is that sizing errors often start here, when a model counts patients and the buyer pays per site.

An official count, such as Eurostat's population and hospital figures, gives either a reference point for the size of the eligible group or an upper limit on it, and the model records which. The payer's published rate, or a price from buyers where no rate is published, turns that group into revenue. The adoption share is an assumption, and the revenue range multiplies the group by that share, the units per patient and the rate.

The published market totals give context for the result and cannot replace it. The €170 billion measures a whole industry on manufacturers' sales, and the IVD figure, for tests run on samples such as blood, is an estimate in every country, so neither can stand in for a count of one company's buyers.

The four running cases show where public sources stop and the company's own evidence takes over.

For the wearable heart monitor from a US company, Germany and the Netherlands, its illustrative launch countries, pay a fee for the monitoring service and publish no device price, so the price has to come from buyers and distributors. France and Belgium are options, each conditional on a payment route that covers the monitor. If France's national list of remote monitoring activities has a line covering the monitor's indication, illustrative assumptions of 500 to 2,000 patients at €50 to €90 a month give €300,000 to €2,160,000 a year. The assumed range of adoption moves that result by a factor of 4. Reaching Belgium's heart failure monitoring scheme, which pays hospitals, would mean widening the intended purpose, which chapter 1 shows can move the device's risk class. Germany's payer states that a class IIb digital health application (DiGA) must show a positive care effect at admission and cannot be listed on trial. On chapter 1's classes, rhythm analysis moves the application to class IIb, so on the authors' reading a model could then no longer assume a trial listing.

For the AI triage software from a German company, the unit of sale is a licence per site on the authors' reading, so the first count to build is the number of urgent care centres in each target country. No source gives the eligible group, and the model cannot be completed until evidence from customers is available.

For the spinal implant, which already sells under its directive certificate, no source gives spinal procedure volumes by country, so the starting point is the company's own sales history, which also identifies its buyers.

For the Swiss company's cardiac troponin test, used near the patient in emergency departments, no source gives the eligible group or the price, and the company's revenue is the price its importing distributor pays. On the authors' reading, the serial-measurement purpose, testing the same patient more than once, multiplies the unit count, so the intended purpose chosen changes the forecast.

Chapter 2 decides the order in which markets are entered, chapter 13 sets out the national payment route in each country, chapter 14 covers budget impact and economic evidence, and chapter 16 decides price, channel and country priority together.

## Sources

The last column gives the latest date on which a statement was checked against the version shown. Live web pages were read as snapshots on that date, and they change without notice.

| Source | Version used | Date of that version | Link | Checked |
|---|---|---|---|---|
| Regulation (EU) 2017/745 on medical devices (MDR), consolidated text | CELEX 02017R0745-20260719 | 19 July 2026 | [Publications Office][MDR] | 29 September 2026 |
| Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), consolidated text | CELEX 02017R0746-20250110 | 10 January 2025 | [Publications Office][IVDR] | 29 September 2026 |
| MDCG 2022-16, guidance on authorised representatives under the MDR and IVDR | Original | October 2022 | [European Commission][MDCG-2022-16] | 29 September 2026 |
| MedTech Europe, *Facts & Figures 2025* | Reissue, file `-digital-1.pdf` | 5 September 2025 | [MedTech Europe][FF] | 29 September 2026 |
| MedTech Europe data hub, Market page | Page marked "Last update 05.09.2025", snapshot | 5 September 2025 | [MedTech Europe][HUB] | 29 September 2026 |
| MedTech Europe data hub, Introduction page | Page marked "Last update 04.09.2025", snapshot | 4 September 2025 | [MedTech Europe][HUB-INTRO] | 29 September 2026 |
| MedTech Europe, *European IVD Market Statistics Report 2025* | 2025 edition, reference years 2023 and 2022 | 18 December 2025 | [MedTech Europe][IVD] | 29 September 2026 |
| Eurostat, population on 1 January (`demo_pjan`) | Dataset update, data to 2025 | 25 September 2026 | [Eurostat][POP] | 29 September 2026 |
| Eurostat, population metadata (`demo_pop`) | Metadata update | 9 February 2026 | [Eurostat][META-POP] | 29 September 2026 |
| Eurostat, health care expenditure by function (`hlth_sha11_hc`) | Dataset update, 2023 used | 16 September 2026 | [Eurostat][SHA-HC] | 29 September 2026 |
| Eurostat, health care expenditure metadata (SHA 2011) | Metadata update | 5 November 2025 | [Eurostat][META-SHA] | 29 September 2026 |
| Eurostat, healthcare expenditure statistics methodology | Page last edited | 19 May 2026 | [Eurostat][SE-SHA] | 29 September 2026 |
| Eurostat, hospital discharges of in-patients by diagnosis (`hlth_tinpat1`) | Dataset update, data 2022 to 2023 | 12 March 2026 | [Eurostat][TINPAT] | 29 September 2026 |
| Eurostat, hospital discharges metadata (`hlth_hosd`) | Metadata update | 15 December 2025 | [Eurostat][META-HOSD] | 29 September 2026 |
| Eurostat, surgical procedures (`hlth_co_proc3`) | Dataset update, data to 2024 | 13 July 2026 | [Eurostat][PROC] | 29 September 2026 |
| Eurostat, health care resources metadata (`hlth_res`) | Metadata update | 10 July 2026 | [Eurostat][META-RES] | 29 September 2026 |
| European Central Bank, US dollar per euro, annual average | Series `EXR.A.USD.EUR.SP00.A`, to 2025 | Fetched 29 September 2026 | [ECB][ECB] | 29 September 2026 |
| GKV-Spitzenverband, DiGA-Bericht 2025 | Report for 1 September 2020 to 31 December 2025 | 1 April 2026 | [GKV-Spitzenverband][DIGA25] | 29 September 2026 |
| GKV-Spitzenverband, DiGA-Bericht 2024 | Report for 1 September 2020 to 31 December 2024, superseded for current figures | 1 April 2025 | [GKV-Spitzenverband][DIGA24] | 29 September 2026 |
| GKV-Spitzenverband, DiGA focus page | Undated page, snapshot | Undated | [GKV-Spitzenverband][GKV] | 29 September 2026 |
| Assurance Maladie, télésurveillance payment conditions | Article dated 27 August 2025, snapshot | 27 August 2025 | [ameli.fr][AMELI] | 29 September 2026 |
| G_NIUS, remote monitoring reimbursement profile | Undated page, snapshot | Undated | [G_NIUS][GNIUS-TLS] | 29 September 2026 |
| G_NIUS, PECAN profile | Undated page, snapshot | Undated | [G_NIUS][GNIUS-PECAN] | 29 September 2026 |
| INAMI, medical mobile apps application page | Latest dated entry, snapshot | 25 June 2026 | [INAMI][INAMI-APPS] | 29 September 2026 |
| INAMI, heart failure remote monitoring page | Undated page, snapshot | Undated | [INAMI][INAMI-HF] | 29 September 2026 |
| KBV, EBM | 3rd quarter 2026 | 17 July 2026 | [KBV][EBM] | 30 September 2026 |
| NZa, telemonitoring page | Snapshot | Undated | [NZa][NZA-TM] | 30 September 2026 |
| CNAM, CCAM | Version 75 | 1 March 2024 | [ameli.fr][CCAM] | 30 September 2026 |
| VZinfo, emergency departments | Snapshot | Undated | [VZinfo][VZINFO] | 30 September 2026 |
| DREES, no. 1305 | Study | July 2024 | [DREES][DREES] | 30 September 2026 |
| FPS Health, institutions 2026 | Snapshot | 2026 | [FPS Health][BE-FOD] | 30 September 2026 |
| Santé publique France, OSCOUR | Bulletin 1090 | 3 March 2026 | [Santé publique France][OSCOUR] | 30 September 2026 |
| European Commission, AI in healthcare study | Snapshot | 17 March 2026 | [European Commission][EC-DH] | 30 September 2026 |
| Vendor A: IMARC, Europe in vitro diagnostics and Europe digital health market pages | Undated marketing pages, snapshots, cited as evidence about the vendor | Undated | [IVD][V-IMARC-IVD]; [digital health][V-IMARC-DH] | 29 September 2026 |
| Vendor B: Expert Market Research, Europe in vitro diagnostics market page | Undated marketing page, snapshot, cited as evidence about the vendor | Undated | [Expert Market Research][V-EMR] | 29 September 2026 |
| Vendor C: MarketsandMarkets, Europe in vitro diagnostics market page | Undated marketing page, snapshot, cited as evidence about the vendor | Undated | [MarketsandMarkets][V-MM] | 29 September 2026 |
| Vendor D: Mordor Intelligence, Europe digital health market page | Undated marketing page, snapshot, cited as evidence about the vendor | Undated | [Mordor Intelligence][V-MORDOR] | 29 September 2026 |
| Vendor E: Nova One Advisor, Europe digital health market page | Undated marketing page, snapshot, cited as evidence about the vendor | Undated | [Nova One Advisor][V-NOVA] | 29 September 2026 |

[MDR]: http://publications.europa.eu/resource/cellar/e56fc708-95ab-11f1-9262-01aa75ed71a1.0004.03/DOC_1
[IVDR]: http://publications.europa.eu/resource/cellar/bb7d3f94-cd06-11ef-be2a-01aa75ed71a1.0007.03/DOC_1
[MDCG-2022-16]: https://health.ec.europa.eu/document/download/0a7613cb-6b9a-4396-a4c6-d2479e43e167_en?filename=mdcg_202216_en.pdf
[FF]: https://www.medtecheurope.org/wp-content/uploads/2025/09/medtech-europe-facts-and-figures-2025-digital-1.pdf
[HUB]: https://www.medtecheurope.org/datahub/market/
[HUB-INTRO]: https://www.medtecheurope.org/datahub/introduction/
[IVD]: https://www.medtecheurope.org/wp-content/uploads/2025/12/ivd-m-report-2025_final.pdf
[POP]: https://ec.europa.eu/eurostat/api/dissemination/statistics/1.0/data/demo_pjan?sex=T&age=TOTAL&sinceTimePeriod=2021
[META-POP]: https://ec.europa.eu/eurostat/cache/metadata/en/demo_pop_esms.htm
[SHA-HC]: https://ec.europa.eu/eurostat/api/dissemination/statistics/1.0/data/hlth_sha11_hc?unit=MIO_EUR&unit=EUR_HAB&unit=PC_CHE&sinceTimePeriod=2021
[META-SHA]: https://ec.europa.eu/eurostat/cache/metadata/en/hlth_sha11_esms.htm
[SE-SHA]: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Healthcare_expenditure_statistics_-_methodology
[TINPAT]: https://ec.europa.eu/eurostat/api/dissemination/statistics/1.0/data/hlth_tinpat1?sex=T&age=TOTAL
[META-HOSD]: https://ec.europa.eu/eurostat/cache/metadata/en/hlth_hosd_esms.htm
[PROC]: https://ec.europa.eu/eurostat/api/dissemination/statistics/1.0/data/hlth_co_proc3?sinceTimePeriod=2019
[META-RES]: https://ec.europa.eu/eurostat/cache/metadata/en/hlth_res_esms.htm
[ECB]: https://data-api.ecb.europa.eu/service/data/EXR/A.USD.EUR.SP00.A?format=csvdata&startPeriod=2019
[DIGA25]: https://www.gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/telematik/digitales/2025_DiGA_Bericht_GKV_SV.pdf
[DIGA24]: https://www.gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/telematik/digitales/2024_DiGA-Bericht_final.pdf
[GKV]: https://www.gkv-spitzenverband.de/gkv_spitzenverband/presse/fokus/fokus_diga.jsp
[AMELI]: https://www.ameli.fr/professionnel-de-la-lpplatm/exercice-professionnel/telesurveillance/telesurveillance-prise-en-charge
[GNIUS-TLS]: https://gnius.esante.gouv.fr/en/financing/reimbursement-profiles/remote-monitoring-reimbursement
[GNIUS-PECAN]: https://gnius.esante.gouv.fr/en/financing/reimbursement-profiles/advance-digital-care-pecan
[INAMI-APPS]: https://www.riziv.fgov.be/fr/professionnels/autres-professionnels/fabricants-et-distributeurs-d-implants-de-div-et-d-autres-dispositifs-medicaux/applications-mobiles-medicales-introduire-votre-demande
[INAMI-HF]: https://www.inami.fgov.be/fr/professionnels/etablissements-et-services-de-soins/hopitaux/soins-hospitaliers/soins-a-distance-telesurveillance-et-orientation-therapeutique-en-cas-d-insuffisance-cardiaque-chronique
[V-IMARC-DH]: https://www.imarcgroup.com/europe-digital-health-market
[V-MORDOR]: https://www.mordorintelligence.com/industry-reports/europe-digital-health-market
[V-NOVA]: https://www.novaoneadvisor.com/report/europe-digital-health-market
[V-IMARC-IVD]: https://www.imarcgroup.com/europe-in-vitro-diagnostics-market
[V-MM]: https://www.marketsandmarkets.com/Market-Reports/europe-in-vitro-diagnostics-market-15932024.html
[V-EMR]: https://www.expertmarketresearch.com/reports/europe-in-vitro-diagnostics-market
[EBM]: https://www.kbv.de/documents/praxis/abrechnung/ebm/2026-3-ebm.pdf
[NZA-TM]: https://www.nza.nl/vraag-en-antwoord/medisch-specialistische-zorg/msrz-hoe-registreren-en-declareren-we-de-inzet-van-een-tool-die-zorg-op-afstand-monitort
[CCAM]: https://www.ameli.fr/fileadmin/user_upload/documents/CCAM_V75.pdf
[VZINFO]: https://www.vzinfo.nl/acute-zorg/regionaal/seh
[DREES]: https://drees.solidarites-sante.gouv.fr/sites/default/files/2024-07/ER1305EMB.pdf
[BE-FOD]: https://www.health.belgium.be/nl/nieuws/2026-4-overzicht-gezondheidszorg-instellingen-2026
[OSCOUR]: https://www.santepubliquefrance.fr/sites/default/files/rdd/document/bullnat_oscour_20260303.pdf
[EC-DH]: https://digital-strategy.ec.europa.eu/en/library/study-artificial-intelligence-healthcare-dissects-digital-health-technologies-europe