Which national route does the product take, and who pays at the end?

Introduction#

A device that complies with the Medical Device Regulation (MDR) or the In Vitro Diagnostic Medical Device Regulation (IVDR), the two Union laws behind CE marking, can be made available in every Member State. Whether a health system pays for it is a separate question. National bodies answer it under national law, country by country.

For a company, the CE mark therefore opens the market without securing any public payment. The national route the product takes decides who applies, what evidence counts, how long the decision takes and who buys at the end.

This chapter explains how that route is identified for a medical device or an in vitro diagnostic medical device (IVD, a test run on samples such as blood), including software. It describes the routes in Germany, France, Great Britain and England, the Netherlands, Italy, Spain, Sweden, Denmark, Norway, Finland and Switzerland.

It then applies the method to four illustrative products. They are a wearable cardiac monitor from a US company and triage software enabled by artificial intelligence (AI) from a European company. The other two are a spinal implant system certified under the former directive and a near-patient cardiac troponin test from a Swiss company. The sources were checked on 30 September 2026, and the answers hold for that date.

1. Why does CE marking leave payment open?#

Where a device complies with the MDR or the IVDR, a Member State may not refuse, prohibit or restrict making it available. The exception is where the regulation provides otherwise. Language is one such provision: each Member State sets the official Union language of the information that accompanies the device. (MDR Articles 10(11) and 24; IVDR Articles 10(10) and 21)

Our reading is that most payment routes rest on a national statute, with the procedural detail set out on the agencies' web pages. The Federal Institute for Drugs and Medical Devices (BfArM) says its own published answers are not legally binding. The procedural statement on the page of the Federal Joint Committee (G-BA) is not law either. (BfArM, FAQ on the Digital Act (DigiG); G-BA, section 137h page)

Does Union health technology assessment change the national file?#

Joint clinical assessment under Regulation (EU) 2021/2282 on health technology assessment (HTA), the HTA Regulation, reaches two groups of devices. One is class IIb or III devices on which expert panels gave a scientific opinion in the MDR Article 54 consultation. The other is class D IVDs on which panels gave views under IVDR Article 48(6). In both cases the device is also subject to selection by the Commission. (HTA Regulation Article 7(1))

The Article 54 consultation covers class III implantable devices, and class IIb active devices that administer or remove a medicinal product. (MDR Article 54(1))

Where a joint assessment has been started, a Member State running its own assessment may not ask nationally for information the developer already submitted at Union level. It annexes the developer's dossier to its national documentation. Once the report is published, it gives the report due consideration and annexes it to the national report. It keeps its competence to draw its own conclusions on overall clinical added value. (HTA Regulation Article 13(1))

Our reading is that a joint assessment can spare a manufacturer repeated clinical submissions, and leaves each national payment decision with the national body that takes it. Selection and the joint procedure are in chapter 12, Does Union health technology assessment reach the product?.

2. What does a national route end in?#

Our reading is that a national route ends in one of four kinds of output, and that the groups overlap in places.

(SGB V §§ 134(1), 135(1), 137e(7), 137h(1); SGB XI § 78a(1); Social security code (CSS), art. L165-2; CSS art. L162-1-23, I and III; Federal Act on Health Insurance (KVG), Article 52(1); Federal Office of Public Health (BAG), fact sheet on digital health applications; Nye metoder, medical devices; KHEntgG § 6(2); CSS art. L165-11, I; Law 16/2003, art. 21(3) and (4); NICE, types of recommendation; MTP council; Health Care Act section 78 a; Danish Medicines Agency, Health Apps Board; Legislative Decree 137/2022, art. 22; TLV, medtech remit; Zorginstituut, digital care handbook)

Each output still needs a buyer. In Norway the procurement body Sykehusinnkjøp handles price negotiations and procurement. Our reading is that no route places the order itself. (Nye metoder, medical devices)

3. Which routes does Germany run?#

The German routes rest on Books V and XI of the Social Code and on the Hospital Remuneration Act.

Digital health applications#

Insured persons are entitled to devices of lower and higher risk class whose main function rests substantially on digital technologies. These are digital health applications (DiGA). The entitlement covers only DiGA that the BfArM has entered in its directory. They are used on the prescription of the treating doctor or psychotherapist, or with the health fund's approval. (SGB V § 33a(1))

Lower risk class means MDR class I or IIa, or the equivalent transitional cases the provision names. Higher risk class means class IIb. In both cases the product has to be already placed on the market as such. Our reading is that a class III product falls in neither. (SGB V § 33a(2))

Outside the entitlement are devices that control active therapeutic products, general everyday objects, and applications intended for use with a specific medicine or a specific Hilfsmittel. A Hilfsmittel is a statutory benefit of its own, covering aids such as hearing aids, prostheses and orthopaedic aids. (SGB V §§ 33(1) and 33a(1))

(SGB V § 139e(2) to (4))

The BfArM's published answer confirms that trial listing is, in the answer's words, at present not provided for a class IIb DiGA. An application for a class IIb DiGA has to carry a study showing medical benefit. (BfArM, FAQ on the DigiG)

The price. The manufacturer and the GKV-Spitzenverband, the national association of the statutory health insurance (GKV) funds, agree prices with effect for all health funds. The agreed amounts apply from the end of the first year after listing. From 1 January 2026 at least 20 per cent of the amount has to be success-based. (SGB V § 134(1))

From 1 January 2027 the price agreement has to include a volume-based discount of at least 2 per cent once dispensings exceed three thousand a year, and of at least 30 per cent once they exceed one hundred thousand. (SGB V § 134(1))

If the parties do not agree within nine months of listing, the arbitration board sets the amounts within three months. Until the agreed amounts apply, the manufacturer's actual prices are paid, up to maximum amounts that the framework agreement under section 134(4) sets for groups of comparable DiGA, with a lower maximum during trial listing. Since July 2026 the framework agreement also has to set a maximum for a DiGA that belongs to no group, calculated as the mean of the group maxima weighted by use. Where a DiGA's price is below the threshold the framework agreement sets, it is paid permanently without a price agreement. (SGB V § 134(2) and (5))

The GKV-Spitzenverband states that the maxima do not apply in the first year until 2,000 codes have been redeemed. As a dated example, its table valid from 1 October 2026 lists group maxima for only two groups, diseases of the urogenital system and mental illness. Its maximum-amounts page gives the current values. (GKV-Spitzenverband, maximum amounts; GKV-Spitzenverband, values from 1 October 2026)

Digital care applications#

People in need of care are entitled to digital care applications (DiPA). The exception is where health insurance or another payer has to provide them because of illness or disability. A DiPA that is a device has to be in the lower risk class. (SGB XI § 40a)

The BfArM lists a DiPA, and the federal association of the long-term care funds agrees an amount within three months of listing. A manufacturer that cannot yet show a care benefit may apply for a trial listing of up to twelve months. (SGB XI § 78a)

New methods in hospital#

Some new methods cannot yet be paid properly by the hospital case flat rates and supplementary payments. For those, the contracting parties at hospital level should agree a time-limited payment outside the revenue budget. That does not apply where the G-BA has excluded the method from funding. (KHEntgG § 6(2))

Before agreeing the payment, the hospital has to obtain information from InEK on whether the method can already be billed properly. The statute requires it by 31 October at the latest. (KHEntgG § 6(2))

The applicant is the hospital, and our reading is that the manufacturer's role is to supply it with the material the request needs. InEK's procedure points for new examination and treatment methods (NUB) say a successful request describes the method, its novelty and the patients. It gives the additional costs, split into staff and material costs where possible. It says why the current case-rate system does not represent the method. (InEK, NUB procedure points)

The G-BA assessment under section 137h#

Section 137h was amended in 2026. The amended rule on what starts the procedure applies only once the G-BA's amended rules of procedure enter into force, which the G-BA states will not be before 31 October 2026. (SGB V § 137h(1); G-BA, section 137h page)

From then, a hospital that first asks InEK about a new method that does not rest solely on giving a medicine also sends the G-BA information on the state of scientific knowledge. For a method resting substantially on a device, this is done in agreement with the manufacturer, with complete data from clinical studies with the device. (SGB V § 137h(1))

An assessment follows only for a new theoretical-scientific concept. That means a principle of action or field of application that differs substantially from approaches already used in inpatient care. (SGB V § 137h(1) and (2))

Within three months the G-BA assesses whether the benefit is sufficiently proven. Failing that, it assesses whether the method has the potential of a necessary treatment alternative. If the method has that potential, the G-BA decides within six months on a trial guideline. If it has neither proven benefit nor potential, no new-method payment is allowed. (SGB V § 137h(1), (4) and (5))

Until the amended rules of procedure enter into force, the G-BA states, submissions stay limited to methods using devices of high risk class. These are MDR class IIb or III devices whose use is particularly invasive. A class III device qualifies if it is active and implantable, or intervenes significantly in the function of an organ such as the heart. (G-BA, news of 17 September 2026; G-BA, rules of procedure, chapter 2, § 30)

An intervention is significant if it alters or replaces the function of an organ or organ system for the long term. It is also significant if it puts the device in direct contact with the heart, the central circulatory system or the central nervous system. A class IIb device qualifies only if it acts on such functions by emitting energy or radioactive substances. (G-BA, rules of procedure, chapter 2, § 30)

Our reading is that, until the amended rules take effect, the procedure does not reach an IVD, a class I or IIa device, or software that emits no energy or radioactive substances. The G-BA's section 137h page carries the date the new rules take effect. The G-BA's advice to manufacturers carries a fee. (SGB V § 137h(6))

The trial guideline a manufacturer can start#

A manufacturer of a device on which a new method substantially rests may apply to the G-BA for a trial guideline. It submits documents showing sufficient potential, and the G-BA decides within three months. If it orders a trial, the applicant commissions an independent scientific institution at its own cost. This does not apply where the applicant withdraws or the G-BA takes the cost on. (SGB V § 137e(7))

In care by office-based doctors and dentists contracted to the funds, a new method may be provided at the funds' expense only if the G-BA has issued recommendations on it. (SGB V § 135(1))

4. Which routes does France run?#

Under the social security code (CSS), health insurance reimburses an individual-use device only once it is entered on the LPPR. Entry follows an opinion of the device commission of the Haute Autorité de santé (HAS). The HAS states that the opinion covers the expected or delivered benefit and, if that is sufficient, the improvement in that benefit. (CSS art. L165-1; HAS, LPPR filing guide)

The HAS also states that filing with it does not replace a separate filing with the Economic Committee for Health Products (CEPS). For a product listed under a brand name, the operator and the CEPS agree the tariff. The CEPS sets it if they do not agree. (HAS, LPPR filing guide; CSS art. L165-2)

The temporary routes#

(CSS art. L162-1-23, I and II; HAS, PECAN page; CSS art. L165-1-1; CSS art. L165-1-5)

To qualify for PECAN, the device is presumed innovative on the basis of the first data available and carries the CE marking for the indication. It complies with personal-data, interoperability and security rules, and exports its data in interoperable formats. PECAN for the indication cannot be combined with the other cover routes the article lists, among them the LPPR and the telemonitoring list. (CSS art. L162-1-23, II and III)

Hospital products#

Some health products are funded inside the hospital tariff for the stay. The State fixes a separate list, the liste en sus, of the conditions in which certain listed products can be paid in addition to that tariff. The list names the only indications that give that right. (CSS art. L165-11, I; CSS art. L162-22-7)

A second hospital list, the intra-GHS list, controls which products hospitals may buy. It applies to products funded in the stay tariff that fall into a homogeneous category set by ministerial order. For those, hospitals may buy, supply and use only products on that list. (HAS, intra-GHS filing guide; CSS art. L165-11, I)

A category covers products that, given their invasive character or risk, need validated clinical efficacy, particular technical specifications or an efficiency assessment. Listing is for a fixed, renewable period and may require further studies. (CSS art. L165-11, II to IV)

Our reading is that this restriction on purchase applies only where a ministerial order has set a homogeneous category that covers the product.

5. What do Great Britain and England require?#

Guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) says every device, including IVDs, has to be registered with it before it is placed on the Great Britain market. An unregistered device cannot lawfully be placed there. (MHRA, Regulating medical devices in the UK)

The same guidance says the MHRA accepts registration only from manufacturers based in the United Kingdom (UK). A manufacturer outside the UK appoints a single UK responsible person for all its devices, who handles tasks such as registration. (MHRA, Regulating medical devices in the UK)

At the check date the guidance allowed devices compliant with the MDR or IVDR to be placed on the Great Britain market until 30 June 2030. The guidance carries the current dates. (MHRA, Regulating medical devices in the UK)

Whether a NICE recommendation comes with funding depends on the programme under which it is made.

(NICE, About technology appraisal guidance; NICE, About HealthTech guidance; NICE, technology appraisal manual; NHS England, MedTech funding mandate guidance)

6. How do the other countries decide?#

The Netherlands#

The Zorginstituut is the national health care institute. It states that a digital care application has to meet "the state of science and practice" to be paid from the basic package, as all insured care does. Where the application is new care in substance, its effectiveness has to be proven by appropriate research. (Zorginstituut, digital care handbook)

For medical-specialist care, the Dutch Healthcare Authority (NZa) runs the optional service, the facultatieve prestatie. Through it insurers and providers agree local initiatives that are hard to fund through the regular national care products. (NZa, optional service page)

At least one provider and one insurer apply together. The service concerns existing medical-specialist care. Providers may bill it only where they have agreements with the patient's insurer. (NZa, optional service page)

The NZa's guide to funding digital care says a care activity may be registered when the care took place at a distance. The exception is where the regulations or the description of the activity limit this. Our reading is that the practical question for a digital product is whether an existing care activity already covers it. (NZa, guide to funding digital care)

Italy#

A distributor that makes devices available in Italy registers in the national database operated at the Ministry of Health. It enters its own data and the devices' identification in the European database on medical devices (EUDAMED). Custom-made devices are excepted, and the IVD decree sets the same duty for IVDs. The distributor updates the entry within thirty days of a change. (Legislative Decree 137/2022, art. 14; Legislative Decree 138/2022, art. 11(1))

A fund for the governance of medical devices is fed by 0.75 per cent of turnover, net of value added tax, from device and large-equipment sales to the Italian National Health Service. IVD suppliers feed it in the same way. (Legislative Decree 137/2022, art. 28; Legislative Decree 138/2022, art. 24)

Law 199/2025 limits the sales on which the contribution is charged to direct sales to the National Health Service. It exempts companies with less than EUR 50,000 of such sales in the year. (Law 199/2025, art. 1(417) and (418))

A second charge applies where regional device spending exceeds its ceiling. From 2017, 50 per cent of the excess is charged to suppliers, in proportion to each supplier's share of regional device spending. (Decree-Law 78/2015, art. 9-ter(9))

A decree published on 7 July 2026 adopts the national HTA programme for devices for 2026 to 2028. In it the national agency for regional health services (Agenas) proposes early identification and assessment of devices. Agenas states that reports received under the programme are considered at prioritisation sessions in July and December. (Legislative Decree 137/2022, art. 22; Decree adopting the 2026-2028 programme; Agenas, reporting form page)

Spain#

New techniques, technologies and procedures have to be assessed by the Spanish network of health technology assessment agencies before their use in the National Health System. Only a technique that passes three tests can enter the common portfolio for public funding. It contributes to prevention, diagnosis or treatment, improves on current alternatives, and, where devices are involved, meets current legislation. (Law 16/2003, art. 21(2) to (4))

Royal Decree 415/2026 of 27 May 2026 sets a new framework for health technology assessment. It covers class IIb and III devices and class D IVDs on which Union expert panels gave an opinion, where selected as its article 6 provides. The decree's cross-reference for that selection is unclear. It also covers any other device, procedure or digital technology its Council for Health Technology Assessment agrees. (Royal Decree 415/2026, art. 6)

From the end of the period set in its third additional provision, the decree applies in phases approved by resolution in the official gazette. Until each phase enters into force, the previous regime continues to apply so far as it does not conflict with the decree. (Royal Decree 415/2026, second transitional provision)

To market devices in Spain, an economic operator has to be in the marketing register of the Spanish Agency of Medicines and Medical Devices (AEMPS) before it starts. Custom-made devices are excepted, and the IVD decree sets the same duty for IVDs. The AEMPS takes the device data for the register from EUDAMED. (Royal Decree 192/2023, art. 18(1); Royal Decree 942/2025, art. 15(1); AEMPS, notice 24/2026)

Sweden#

TLV states that each region and municipality decides for itself which devices it buys and uses. The regions' MTP council has representatives from six healthcare collaboration regions. It recommends on the orderly introduction of devices, mainly new and costly ones. Its recommendations are intended to be strongly guiding. (TLV, medtech in Sweden; MTP council)

After a positive recommendation, each region decides whether to introduce the product under its own routines. (Introduction page)

The council decides which products get a recommendation, on set priority criteria. The evidence usually includes a health economic evaluation, a legal analysis of information technology security and personal data, a purchasing strategy, and clinical expert dialogue. (Decision page)

TLV makes the health economic assessment on the council's order, from a dossier the company supplies. Its benchmark is that its own handling time should not exceed 180 days. (Health economic assessment page; TLV, device assessments)

Denmark#

The Health Apps Board, set up under the Health Act, assesses health apps and recommends them to citizens and health professionals on sundhed.dk. It assesses evidence of effect, usability, price and societal value. It expects the price to be proportionate to the effect. (Health Act § 193 c; Danish Medicines Agency, Health Apps Board)

The purchase runs through the regions. Danske Regioner states that a substantial part of the regions' buying is subject to mandatory tendering. (Regionernes Fælles Indkøb)

Norway#

Under the Specialist Health Services Act, the regional health authorities are to ensure a common system for deciding which methods the specialist health service can offer. That system, Nye metoder, covers devices as well as medicines, procedures and diagnostic tests. (Specialist Health Services Act § 4-4; Nye metoder, medical devices)

A method is to be reported where it meets all of criteria A to C and at least one limb of criterion D. Under A, the regional health authorities hold the financing responsibility, as they do when a specialist-service doctor directs the treatment. B is CE marking. C is added benefit on patient outcomes against current treatment in Norway, meaning longer life or better quality of life; small incremental improvements that give no substantial change in clinical effect do not count. D is expected costs above 50 million kroner at the end of year 3, or large consequences for staffing or organisation. Bestillerforum, the forum that orders assessments, then decides whether to assess the method, and of which type. (Nye metoder, medical devices)

The medical products directorate (DMP) assesses devices, and only CE-marked devices are eligible for its assessment. Beslutningsforum decides whether a method is introduced. While a method is being handled in Nye metoder, the health trusts are not to buy it. (DMP, submission page; Nye metoder, medical devices)

Finland#

Methods with an unreasonable risk, or with a limited effect at unreasonable cost, are excluded from the health care service range. A council attached to the Ministry of Social Affairs and Health recommends on what belongs in the range. (Health Care Act sections 7 a and 78 a)

A wellbeing services county plans and provides care as clients' need requires. Sickness insurance does not reimburse care supplies, assistive devices or prostheses. (Act 612/2021, section 4; Health Insurance Act, chapter 2, section 3)

Switzerland#

A manufacturer without a seat in Switzerland may place devices on the Swiss market only through an authorised representative with a seat there, on a written mandate. That is the rule of the Medical Devices Ordinance (MepV) and the In Vitro Diagnostics Ordinance (IvDV). Swissmedic states that it applies to manufacturers established in the European Union or the European Economic Area as well. (MepV Article 51; IvDV Article 44; Swissmedic, obligations of economic operators)

Manufacturers or their representatives, and importers, register the required data with Swissmedic before first placing a device on the market. (MepV Article 55; IvDV Article 48)

Swissmedic states that Switzerland set up these measures because the mutual recognition agreement with the Union was not updated on 26 May 2021. A package of Switzerland-Union agreements went to Parliament on 13 March 2026. (Swissmedic, obligations of economic operators; Federal Department of Foreign Affairs)

Under the Federal Act on Health Insurance (KVG), compulsory health insurance pays for benefits that are effective, appropriate and cost-effective. The list of means and objects (MiGeL) holds products applied by insured persons, by a lay helper, or by nursing services. (KVG Article 32; BAG, MiGeL page; BAG, MiGeL application handbook)

The commission for analyses, means and objects assesses an application. It recommends to the Federal Department of Home Affairs, which decides. (BAG, MiGeL application handbook)

The Federal Office of Public Health (BAG) states that compulsory insurance can pay for digital health applications with a medical purpose on the same three criteria. An application used by the insured person, or with a lay helper, counts as a means and object. The MiGeL entry then determines whether insurance has to pay and the maximum amount it pays. (BAG, fact sheet on digital health applications)

7. Where do the temporary routes end?#

Several routes, which this chapter calls bridges, give cover or a listing for a limited time while evidence is built. Each ends at a written deadline or trigger, as the German and French sections set out. (SGB V § 139e(4); CSS art. L162-1-23, I; CSS art. L165-1-5)

Our reading is that a bridge defers the full evidence requirement and removes none of it, so the filing due at its end should be planned before the bridge is applied for.

8. How the answer is reached#

The route is settled for one product in one country at a time. The answers depend on one another in this order:

1. The scope comes first. The intended purpose, class, setting, user and company role come from chapter 1, on qualification, class and roles. Whether a product can use the German digital routes depends on its class. PECAN requires the CE marking for the indication claimed. (SGB V § 33a(2); CSS art. L162-1-23, II)
2. Any national registration or representative comes before the first sale. Great Britain, Switzerland, Spain and Italy each add a registration or a representative of their own, as their sections set out.
3. Every route the product fits stays in view. The German hospital route runs through the hospital, and the German digital route through a prescription or the fund's approval. (KHEntgG § 6(2); SGB V § 33a(1))
4. The decision the route ends in is read in the words of the provision that governs it, and its output placed in one of the four groups in section 2.
5. The applicant follows from the route. Where the manufacturer is not the applicant, as on the German hospital route, its role is to supply the applicant with what the application needs.
6. The payer and the buyer are separate. The payer is the fund, insurer or public body whose money moves. The buyer orders the product, such as a prescriber, a hospital or a region.
7. The evidence is read in the route's own terms. Germany asks for positive healthcare effects and France for sufficient benefit. The Netherlands asks for the state of science and practice, and Norway for added benefit. (SGB V § 139e(2); HAS, LPPR filing guide; Zorginstituut, digital care handbook; Nye metoder, medical devices)
8. Statutory periods come from the law. Windows tied to calendar dates come from the web page of the body that sets them, and hold only for the date on which that page was read.
9. The deadline at the end of any bridge determines when the next filing is due.
10. Union health technology assessment is checked. If a joint report exists or has started, the national body may not ask again for information already submitted at Union level. (HTA Regulation Article 13(1))

9. The four running cases#

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

On our reading the monitor's hardware is class IIa. Its companion application is classified separately: class IIa if it only records for later review, and class IIb if it analyses the rhythm to guide a physician's diagnosis. The application is planned as recording only. As illustrative assumptions, the company launches in Germany and the Netherlands together, and the application runs on the patient's phone. The company wants the application on the German digital route.

(SGB V §§ 33(1), 33a, 134 and 139e; BfArM, FAQ on the DigiG; GKV-Spitzenverband, maximum amounts; GKV-Spitzenverband, values from 1 October 2026; Zorginstituut, digital care handbook; NZa, optional service page; MDR Article 54(1); HTA Regulation Article 7(1))

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

Triage nurses in adult urgent care centres use the tool to suggest how soon each patient should be seen. It serves patients the nurse has already assessed as having no life-threatening condition, and the nurse confirms or changes the suggestion. Class IIa to III are all arguable under Rule 11, and the tool is planned as class IIb. As illustrative assumptions, its home Member State is Germany and Sweden is the first market after it.

At the planned class IIb, a German DiGA application would have to show a medical benefit, without trial listing. The entitlement belongs to the insured person. Our reading is that a tool nurses run for every patient in a centre does not match that model on its face. The route that fits it more closely is the German hospital route for new methods. (SGB V §§ 33a(1), (2), 139e(2) and (4))

(KHEntgG § 6(2); InEK, NUB procedure points; SGB V § 137h(1), (2) and (6); G-BA, rules of procedure, chapter 2, § 30; MTP council; Decision page; Recommendation page; TLV, device assessments; MDR Article 54(1); HTA Regulation Article 7(1))

What the AI Act adds is in chapter 10, Which AI and cybersecurity rules reach the product, and from when?.

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

Chapter 1 classes the system by component: the interbody cage class III, screws and plates class IIb, hooks class IIb on the reading in Medical Device Coordination Group (MDCG) guidance 2021-24 rev.1, and rods, wires and pins open. As illustrative assumptions, the system carries a certificate under Directive 93/42/EEC, the former Medical Devices Directive, and seeks its first MDR certificate. It is sold in Germany and Italy under that certificate and has not yet entered France.

(MDR Article 54(1); HTA Regulation Article 7(1); HAS, CNEDiMTS principles, volume 1; CSS art. L162-22-7; CSS art. L165-1; HAS, LPPR filing guide; KHEntgG § 6(2); SGB V § 137h(1) and (6); G-BA, rules of procedure, chapter 2, § 30; Legislative Decree 137/2022, arts 14 and 28; Law 199/2025, art. 1(418); Decree-Law 78/2015, art. 9-ter(9))

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

The Swiss company has no Union entity. Its test measures cardiac troponin near patients in hospital emergency departments, read on a point-of-care analyser the company supplies. Chapter 1 plans it as class C. As illustrative assumptions, it was placed on the Union market under a declaration of conformity drawn up under Directive 98/79/EC before 26 May 2022, without a notified body. Distributors already sell it in Germany, the Netherlands, Belgium and Austria, and Switzerland is the home market.

(HTA Regulation Article 7(1); IvDV Article 48; KHEntgG § 6(2); G-BA, rules of procedure, chapter 2, § 30; SGB V § 137h(1), (2) and (6); NZa, guide to funding digital care; NZa, optional service page)

10. When specialist help is worth paying for#

• A German digital route is the plan. Whether the product is eligible, and the evidence its class demands, determine the budget. (SGB V § 139e(2) and (8))
• A new hospital method is involved in Germany. Until the G-BA's amended rules of procedure take effect, the interim scope of section 137h decides whether the G-BA assesses. A section 137e(7) trial puts the evaluation cost on the applicant, unless it withdraws or the G-BA takes the cost on. (SGB V §§ 137e(7) and 137h(1); G-BA, news of 17 September 2026)
• A French bridge is proposed. PECAN excludes other cover routes for the same indication. (CSS art. L162-1-23, III)
• The company sells directly to the Italian health service. The fund contribution and the payback rules need a tax and legal view. (Decree-Law 78/2015, art. 9-ter(9))
• The company sells into Switzerland from outside it. A Swiss authorised representative and registration before placing are conditions of access. (MepV Articles 51 and 55)
• The company is Swiss and sells into the Union. Chapter 1 sets out the sole authorised representative it needs in the Union. On our reading, whether that requirement changes depends on whether the mutual recognition agreement with the Union is updated. (Federal Department of Foreign Affairs)

Conclusion#

The product's intended purpose, class, setting, user and company role, set out in chapter 1, decide which national payment routes it can enter, and its class, the risk category set under the MDR or IVDR, matters most.

Any registration or representative a country requires has to be in place before the first sale there. The route then sets the decision, the applicant, the evidence and the timing. Whatever the route ends in, a buyer such as a prescriber, a hospital or a region still has to order the product.

A temporary route pays for or lists a product for a limited time while evidence is built, and ends at a written deadline or trigger. On our reading, it defers the full evidence requirement without removing it, so the filing due at its end should be planned before the company applies.

The four running cases come out as follows. On our reading, the phone application of the wearable heart monitor from a US company has an arguable case on the German route for digital health applications (DiGA), which the statutory health funds pay for, at its planned class IIa. Four questions stay open.

The first is whether the application's main function rests substantially on digital technologies. The second is whether the wearable is itself a Hilfsmittel, a statutory aid such as a hearing aid, which would exclude the application. The third is whether a new rhythm-analysing algorithm moves it to class IIb, which would require proof of medical benefit and close trial listing. The fourth is whether the maximum price for a DiGA in no product group has yet been set. In the Netherlands the company would deal with an insurer and a cardiology provider, which can apply together for the optional service, a locally agreed payment for hospital specialist care.

For the triage tool, the AI software from a German company that suggests how soon each patient should be seen, the German route that fits more closely is the hospital route for new methods. The hospital applies, with the company's help, only if the centre's urgent-care patients are billed as inpatient cases and a triage aid counts as a new method.

The interim scope of section 137h, under which the Federal Joint Committee (G-BA) assesses new hospital methods, does not reach the tool. Once the G-BA's amended rules take effect, an assessment would follow only for a principle substantially different from approaches already used in hospital care. In Sweden each region decides for itself whether to introduce it.

At the check date the cage of the spinal implant system from a European company falls outside the French restriction on hospital purchase, the intra-GHS list, because no category set by ministerial order covers a spinal implant. The implant's first French step is the listing application to the HAS, France's national health authority, for the list of reimbursable products and services (LPPR). Its French revenue would depend on the prices hospitals negotiate and on whether the liste en sus, which pays products on top of the hospital stay tariff, names its indication.

The near-patient test, a cardiac troponin blood test from a Swiss company, is outside joint clinical assessment, the EU-level review of clinical evidence, which reaches only class D IVDs, the highest-risk tests. On our reading its German route runs through a hospital's request to InEK, the institute that runs the hospital case-payment system, and covers only patients admitted and billed under the case rates.

Chapter 14 covers economic evidence that can be reused across these routes. Chapter 15 covers public procurement and preparing the evidence before the contract notice is published, and chapter 16 covers choosing markets, channels and price together. Instruments that can fund work on these routes are listed in register 6, the funding instrument inventory.