Which countries come first, and who sells at what price?

Introduction#

A company entering the European Union (EU) has to decide which countries come first, who sells to the customer in each, and what the company itself is paid. Each answer changes the other two. The national reimbursement route, the way a health insurer or health system pays for a device, decides who pays, and so which sale the company has to price.

This chapter covers medical devices and in vitro diagnostic medical devices (IVDs, tests run on samples such as blood), including software, for companies inside or outside the Union. They fall under two EU regulations, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).

It applies the method to four illustrative products used throughout the book. The wearable cardiac monitor comes from a United States (US) company that needs a sole authorised representative, a single party established in the Union and appointed in writing to act for it. The triage software enabled by artificial intelligence (AI), from a Union company, sells directly to hospitals and through an app platform.

The spinal implant, CE marked under the earlier Medical Devices Directive (Directive 93/42/EEC) and seeking its first certificate under the MDR, sells through distributors to public hospitals. The near-patient cardiac troponin test, a blood test used in hospital emergency departments, comes from a Swiss company. In each of its Union markets it has an importer, the Union business that first places the test on the Union market. The sources were checked between 27 and 30 September 2026.

1. Why are countries, channels and price one decision?#

The choice of who sells to the end customer decides which sale is the company's own. Our reading, our label for an interpretation of the text, is that where a partner buys from the manufacturer and resells to a hospital, the hospital's price belongs to the partner's contract. The manufacturer's price is then its sell-in, the price the partner pays it.

The regulatory roles also follow from who sells, as section 8 sets out.

Who pays depends on the country. In Germany, the national association of statutory health insurers, the GKV-Spitzenverband (GKV for gesetzliche Krankenversicherung, statutory health insurance), agrees the amounts for a listed digital health application with its manufacturer. The manufacturer gives the GKV-Spitzenverband details of the amount it actually charges self-payers and in other European countries. Our reading is that a price set first in another country can therefore influence the amount agreed in Germany. (SGB V section 134(1))

The HTA Regulation states that it does not interfere with national pricing and reimbursement decisions. (HTA Regulation Art. 1(2))

MDCG documents are guidance, and the regulations are the law. Chapter 1, on qualification and classification, explains their legal status.

2. What does the CE marking leave to each country?#

The information that accompanies a device has to be in the official Union language or languages that the Member State where it is made available determines. For self-testing and near-patient tests, it also has to be easily understandable. (MDR Art. 10(11); IVDR Art. 10(10))

Member States may keep or introduce their own registration of distributors. MDCG 2021-27 rev.1 says distributors do not register in EUDAMED, the European database on medical devices, but may face national registration. Importers register in EUDAMED. (MDR Art. 30(2); IVDR Art. 27(2); MDCG 2021-27 rev.1, p. 11)

A national authority can still act against a certified device. Against an unacceptable risk, it requires corrective action that can restrict, withdraw or recall the device. Against non-compliance without such a risk, it requires the operator to end the non-compliance within a stated period. (MDR Art. 95(1), 97(1); IVDR Art. 90(1), 92(1))

3. What is registered once for the whole Union?#

Manufacturers, authorised representatives and importers submit their registration information to the electronic system before placing a device on the market, if they have not already registered. (MDR Art. 31(1); IVDR Art. 28(1))

As a dated example, the Commission's timeline gives 28 May 2026 as the start of mandatory use of the unique device identifier (UDI) and device registration module. A Commission questions-and-answers (Q&A) document, which the Commission has not formally endorsed, says a device first placed on the market from that date is registered before its first unit is placed. (EUDAMED legacy timeline; EUDAMED Q&A, Q7)

For certain devices already on the market, manufacturers enter the device registration information no later than 12 months from the Commission's notice, published in the Official Journal on 27 November 2025. The same deadline applies to such devices that are also placed on the market from six months after the notice. Chapter 9 covers registration and its conditions. (MDR Art. 123(3)(e); Decision (EU) 2025/2371)

4. How much does each country weigh?#

MedTech Europe, the industry's trade association, names these five as the biggest European medical technology markets. (MedTech Europe, Facts & Figures 2025, p. 18)

(MedTech Europe, Facts & Figures 2025, pp. 19 and 20)

Our reading is that a national share measures all device value sold in a country, from implants to consumables. It says nothing about a particular product category or about whether a national route to payment is open, so it should weight the order of countries only once the route and the buyer are known.

5. What do Great Britain and Switzerland add?#

The Medicines and Healthcare products Regulatory Agency (MHRA) says every device, including IVDs, has to be registered with it before being placed on the Great Britain market. It also says a manufacturer based outside the United Kingdom (UK) appoints a single UK responsible person for all its devices. Importers and distributors need not appoint one, and may act as one. (MHRA, Regulating medical devices in the UK)

As a dated example, the MHRA's guide updated on 20 February 2026 gives the dates until which Great Britain accepts CE-marked devices.

(MHRA)

Those dates are set in law. The Medical Devices Regulations 2002, UK statutory instrument (SI) 2002/618, end the provisions accepting compliance with those directives in 2028. The provisions accepting compliance with the MDR, the IVD directive and the IVDR end in 2030. (SI 2002/618 reg. 1ZA)

The MHRA's consultation on indefinite recognition of CE-marked devices closed on 10 April 2026. On 30 September 2026 its GOV.UK page showed the MHRA still analysing the feedback. (MHRA consultation)

The Swiss Medical Devices Ordinance (MepV) requires a manufacturer based outside Switzerland to authorise a person based there, by written mandate, before placing its products on the market. Manufacturers or their authorised persons, and importers, register the required details with Swissmedic before first placing a product on the market. (MepV Art. 51(1), 55(1))

Separately, each product's UDI information is registered with Swissmedic, as a dated example by 31 December 2026 for products placed on the market since 1 July 2026. Article 108(2) sets that date for the UDI registration only, and says nothing about registering the manufacturer, authorised person or importer. (MepV Art. 17(5), 108(2))

The Commission's notice of 26 May 2021 says the trade-facilitating effects of the EU-Switzerland mutual recognition agreement for devices under the MDR ceased from that date. They include mutual recognition of conformity assessment results and the absence of a need for an authorised representative. The two sides signed a package of agreements on 2 March 2026, which lets each side advance its ratification. It updates the agreement on mutual recognition of conformity assessment. (Commission notice, 26 May 2021; Commission press release IP/26/505)

6. Who decides and who pays in each country?#

The national route decides who pays, and who pays decides which transaction the company has to price. Chapter 13 covers the routes, including who pays in the Netherlands, Sweden and England. The cited national instruments are the official sources.

(SGB V sections 33a(1), 134(1); CSS article L162-1-23; NZa policy rule 2026, article 12b(1), (5); Specialist Health Services Act, section 4-4; Nye metoder; MTP-rådet page; Samverkansmodellen annual report 2025)

In France, hospital purchase of products that are financed through the hospital stay benefits and fall in designated homogeneous categories is limited to listed products. An establishment that buys or uses an unlisted product in such a category is liable to a financial penalty. The penalty is capped at its purchase cost of those products in the previous year. Our reading is that the limit and the penalty make listing a precondition for selling a product in such a category to a hospital, and that precondition has to be settled before any price is discussed. (CSS article L165-11; CSS article L165-12)

7. Does a joint clinical assessment change the price?#

The HTA Regulation provides for joint clinical assessment at Union level. Class IIb and III devices with an expert panel opinion given in the clinical evaluation consultation procedure, and class D IVDs with expert panel views, are subject to it if the Commission selects them. Once a joint report is published or an assessment has started, a Member State's own assessment gives due consideration to the report and the other information on the Union's platform. The Member State does not ask again for evidence already submitted at Union level. (HTA Regulation Art. 7(1), 13(1)(a), (d))

As a dated example, the Commission's list of ongoing assessments, with data extracted on 17 September 2026, covers medicines only by its own terms. It therefore cannot show whether a device assessment has started. Chapter 12 covers whether Union HTA reaches a device. (Commission list of ongoing joint clinical assessments)

8. What decides each party's role in the supply chain?#

Under the MDR the economic operators are the manufacturer, the authorised representative, the importer, the distributor, and the person referred to in its Article 22(1) and (3). (MDR Art. 2(35))

(MDR Art. 2(28), 2(32) to (35); IVDR Art. 2(27))

MDCG 2021-27 rev.1 draws the line between importer and distributor at placing on the market. The qualifying event is a transfer of ownership, possession or any other property right, which need not involve physical handover. (MDCG 2021-27 rev.1, p. 4)

(MDCG 2021-27 rev.1, pp. 5, 7 to 10, 13 and 14)

A manufacturer outside the Union needs a sole authorised representative whatever channel it picks. A change of representative needs an agreement between the manufacturer, the incoming representative and, where practicable, the outgoing one. MDCG 2022-16 reads "where practicable" narrowly, leaving the outgoing representative out mainly where it has ceased to exist or cannot be traced. (MDR Art. 11(1), 12; IVDR Art. 11(1); MDCG 2022-16, pp. 8 and 9)

A commercial agent is a self-employed intermediary with continuing authority to negotiate the sale or the purchase of goods for a principal, or to negotiate and conclude such transactions in the principal's name. The Commission's guidelines on vertical restraints list, among the conditions for a genuine agency, that the agent does not acquire property in the goods or keep stock at its own risk. (Directive 86/653 Art. 1(2); Guidelines on vertical restraints, para. (33))

Our reading is that an agent that holds no property right in a device has no economic operator role under the MDR, because the guidance treats a transfer of ownership, possession or another property right as the event that places a device on the market. The guidance does not address sales agents expressly.

Our reading is also that the directive may not reach every partner paid a commission. Its definition of a commercial agent refers to the sale or purchase of goods, and it does not say whether a software licence is a sale of goods. A partner that only introduces buyers, with no continuing authority to negotiate, may fall outside it.

9. When does a partner become the manufacturer?#

A distributor, importer or other person takes on the manufacturer's obligations if it makes a device available under its name, registered trade name or registered trade mark. The exception is a distributor or importer that agrees with the manufacturer that the manufacturer stays named on the label and responsible. Changing the intended purpose, or modifying the device so compliance may be affected, has the same effect. (MDR Art. 16(1); IVDR Art. 16(1)(a))

Translating the manufacturer's information, and changing outer packaging where the market needs it and the device's condition cannot be affected, are not modifications for that purpose. Article 16(3) and (4) attach conditions to a distributor or importer doing either. (MDR Art. 16(2) to (4); IVDR Art. 16(2))

(MDR Art. 16(3), (4); IVDR Art. 16(4))

MDCG 2021-26 reads Article 16(2) to (4) as applying only to importers and distributors. It excludes operators relabelling on the manufacturer's behalf and under its control. (MDCG 2021-26, pp. 2 and 3)

10. What are an importer's and a distributor's duties?#

(MDR Art. 13(2) to (4), (6), (8), 14(1) to (3), (5), 25(1), (2), 30(3); IVDR Art. 13(2), 14(2), (5), 22(1), (2))

MDCG 2021-27 rev.1 says a manufacturer or representative cannot perform the importer's or distributor's verification checks for them. Operational tasks can be subcontracted, and the importer or distributor keeps its obligations. (MDCG 2021-27 rev.1, p. 11)

The identification duty runs for the Article 10(8) period: at least 10 years after the last device is placed on the market, and at least 15 years for implantable devices. Our reading is that it is owed to the competent authority, and that a full commercial account list reaches the manufacturer only through a negotiated clause. (MDR Art. 10(8))

A manufacturer that finds a device non-conforming takes corrective action immediately. It informs its distributors and, where applicable, its authorised representative and importers. It keeps its post-market surveillance system up to date, the systematic procedure by which manufacturers, with other economic operators, collect and review experience from devices on the market. Our reading is that the partner's complaint register feeds that system. (MDR Art. 2(60), 10(10), (12); IVDR Art. 10(11))

11. Is an app platform a distributor?#

MDCG 2025-4 treats a manufacturer's upload of a software app to an app platform as placing it on the market. It treats a platform that makes the app directly available to users, for example by transferring a right in it, as a distributor under Article 14. It treats the platform as an importer under Article 13 where the manufacturer is outside the Union and the platform is in it. On the same reading, a platform acting only as an intermediary service, including as an online marketplace, should not be considered either. (MDCG 2025-4, pp. 4 to 6)

12. What does Union law fix in a commercial agency contract?#

The agency directive, Directive 86/653/EEC, sets the rules in the table below. Each Member State brings them into force through its own law, and some choices are left to it. (Directive 86/653 Art. 22(1))

(Directive 86/653 Art. 6(2), 7(2), 14, 15(1), (2), 17(1) to (3), (5), 18, 19, 20)

Our reading is that the one-year cap is written for the indemnity alone, so the directive sets no ceiling on compensation.

13. What does competition law allow in a distribution agreement?#

The Commission's guidelines on vertical restraints, which are guidance, treat an agent that bears no significant financial or commercial risk as falling wholly or partly outside the Treaty's ban on anti-competitive agreements. They read those conditions narrowly, whatever the parties call the agreement. (Guidelines on vertical restraints, paras. (1), (2) and (30))

For distributors, the vertical block exemption regulation, Regulation (EU) 2022/720, exempts supply agreements from that ban where the supplier's and the buyer's market shares each do not exceed 30%. The parties also have to be non-competitors, with narrow exceptions, so a distributor that makes a competing device may fall outside it. (Regulation 2022/720 Art. 2(1), (4), 3(1))

Our reading is that in competition law a distributor is any buyer that resells, so an MDR importer can be an exclusive distributor under this Regulation.

(Regulation 2022/720 Art. 1(1)(h), (l), (m), 4(a), (b)(i), 5)

Article 4 takes a whole agreement outside the exemption where its object is a listed restriction, while Article 5 removes only the obligation concerned. As a dated example, Article 11 sets the Regulation's expiry on 31 May 2034. (Regulation 2022/720 Art. 4, 5(1), 11)

14. What do filed distribution agreements show?#

Two European agreements filed as exhibits with the US Securities and Exchange Commission (SEC) show what such contracts contain. In an exclusive distribution agreement filed in 2019, CytoSorbents Europe GmbH appointed AFERETICA s.r.l. as exclusive distributor for listed products. An amendment filed with it changes only the minimum purchases and the term. (Exhibit 10.23, clause 1.1; Exhibit 10.24)

Under its clause 1.9, the distributor refers orders from outside its territory to the company and may not deliver outside it. Our reading is that this restricts passive sales, which takes an agreement outside the 2022 exemption regulation.

The distributor sets its own resale prices, under a redacted floor for the average end-customer price. Article 4(a) names a minimum resale price among the restrictions the exemption does not cover. (Exhibit 10.23, clause 2.7)

In a 2005 agreement filed by LeMaitre Vascular, Biomateriali Srl appointed Edwards Lifesciences AG as exclusive distributor in a listed territory. Edwards took on customer service, including forwarding product complaints to Biomateriali on a timely basis. (Exhibit 10.35, clauses 1.1 and 2.3)

Both filings redact parts of their text under a confidential treatment request and give no benchmark for margins, so a company has to obtain margins, commission rates and volumes from partners directly.

15. Which price rules apply to each transaction?#

Directive 2014/24/EU on public procurement applies where a contracting authority buys at or above set thresholds. A contracting authority is the State, a regional or local authority, a body governed by public law, or an association of them. As a dated example, the threshold for supply contracts awarded by sub-central contracting authorities is EUR 216,000 from 1 January 2026. The Commission revises the thresholds every two years, and its delegated regulation, currently 2025/2152, is the official source for the figure. (Directive 2014/24 Art. 2(1), 4(c); Delegated Regulation 2025/2152)

(Directive 2014/24 Art. 33(1), 50(1), 67(1), (2), 72(1)(a); Annex V, Part D, point 13)

Chapter 15 covers the procurement procedure.

For a listed digital health application in Germany, the statute sets floors on the agreement. From 1 January 2026, at least 20 per cent of the agreed amount has to be success-dependent. From 1 January 2027, the agreement carries a volume discount of at least 2 per cent above three thousand dispensings a year. Above one hundred thousand, it is at least 30 per cent. (SGB V section 134(1))

Until the amounts are set, the manufacturer's actual prices apply. The framework agreement under section 134(4) is a national agreement, distinct from a procurement framework agreement. It sets thresholds below which remuneration is paid without a separate agreement, and maximum amounts for the interim period. Without agreement within nine months of listing, an arbitration board sets the amounts within three months. The negotiations are confidential. (SGB V section 134(1), (2), (5))

As a dated example, a GKV-Spitzenverband notice captured by the Internet Archive on 24 September 2026 gives a threshold of EUR 0.84 per calendar day including value added tax. It applies from 1 October 2026. A later change to the notice cannot be excluded, and the GKV-Spitzenverband's current notice is the official source. (GKV-Spitzenverband notice, via Internet Archive)

16. How does a partner's margin compare with a direct team?#

Our observation, our label for a view from practice that no source states, is that four different figures are all called margin. They are a discount off list, a gross margin on the partner's resale price, a mark-up on the manufacturer's transfer price, and a commission on invoiced value.

Computation, on illustrative assumptions. The assumptions are a list price of 100, a transfer price to the partner of 60, and a partner that resells at list. The discount off list is 40 on 100, which is 40 per cent. The partner's gross margin on resale is 40 on 100, also 40 per cent. The mark-up on the transfer price is 40 on 60, which is 66.7 per cent.

Computation, on illustrative assumptions. The assumptions are a list price of 1,000, a hospital price of 820 awarded under a framework, and 200 units bought in the year. Supplying directly, the manufacturer realises 820 a unit, 18 per cent below list. Supplying through a partner that takes a gross margin of 25 per cent on its resale price, the partner keeps 205. The manufacturer's sell-in, the price the partner pays it, is 615, which is 38.5 per cent below list.

Taking the same 25 per cent off the 1,000 list price instead gives 250 and a sell-in of 570. The error is 45 a unit, or 9,000 over the year's 200 units. A revenue model that records the hospital price of 820 as the manufacturer's revenue is counting a sale the partner made.

The reversal margin is the partner margin at which the direct and partner routes give the same contribution, where contribution means revenue less the costs that differ between the two routes. Where the better route stays the same at both ends of every input estimated as a range, the choice of route is a decision. Where the better route changes within a range, the choice is a hypothesis with a test attached.

17. How the answer is reached#

The answers depend on one another in this order, and a change at any step reopens the steps after it:

1. Scope, from chapter 1 on qualification and classification, chapter 2 on market sequence, and chapter 13 on national routes.
2. What repeats in each country: the language, any national distributor registration, and the British and Swiss steps in section 5.
3. Payer and buyer. A contracting authority buying at or above the threshold uses a procurement procedure. Our reading is that where no national route is open, the case for entering the country rests only on the named accounts and that procurement procedure. (Directive 2014/24 Art. 4)
4. Accounts. Our observation is that the named accounts carrying the revenue, and the service each needs, set the size of the team.
5. Roles, produced by the act each legal entity performs on the device, as in figure 16.1, with Article 16 for own-name sales, translation or repackaging.
6. Duties and data, allocated by Articles 13, 14 and 25. Our reading is that the distributor's duty to provide information on request supports a data schedule with named fields, a frequency and a format. (MDR Art. 14(5))
7. Contract form. A distributor buys and resells, an agent negotiates for the principal, and a subsidiary buying from a manufacturer outside the Union is its importer. Sections 12 and 13 then apply.
8. Price, reconciled separately for each transaction, stating which definition of margin is used, as in figure 16.2. Two transactions are added together only at the level of total receipts.
9. The reversal margin, the partner margin at which direct and partner supply break even, tested at both ends of every input estimated as a range, as in section 16.
10. Waves. Countries are ranked on whether a national route is open, the named accounts, whether someone is available to take each role, and whether the choice between direct and partner supply holds across the ranges tested in step 9. Market share weights the order only afterwards. Where Germany's digital route applies, prices elsewhere are set with the German negotiation in view.
11. Exit. Our reading is that the forwarding and identification duties attach to devices already made available, so they outlast the contract. A change of authorised representative follows Article 12.
12. Review triggers, such as a first contract, a route decision or a partner's first full reporting period, reopen the ranking.

18. The four running cases#

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

The monitor records heart rhythm continuously for later review by a clinician, with a companion application. Chapter 1 classes the hardware as class IIa under Rule 10, on our reading. It classes the application separately: class IIa if it only records, class IIb if it analyses the rhythm to guide a diagnosis. The planning assumption is that it only records. As an illustrative assumption of this book, the company enters Germany and the Netherlands together, and France later.

Which German route fits the application is a question for chapter 13, so the price reconciliations for the hardware and the application stay separate until that question is answered. A partner that translates the instructions has to meet the Article 16(3) and (4) conditions. Our reading is that a partner using translated text supplied by the manufacturer does not have to meet them. (MDR Art. 16(3), (4))

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

The triage tool is AI-enabled software that suggests how soon each patient should be seen. Triage nurses in adult urgent care centres use it for patients they have already assessed as having no life-threatening condition, and confirm or change the suggestion. Chapter 1 plans it as class IIb, since class IIa to III are all arguable under Rule 11. The company sells it directly to hospitals and, as an illustrative assumption of this book, through an app platform.

Our reading is that whether the agency directive applies decides whether the reversal margin calculation includes the cost of ending the agency, meaning the notice period and any termination payment. Chapter 10, on AI and cybersecurity obligations, covers whether the AI Act gives the reseller or the platform duties of its own.

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

The implant is a spinal implant system: an interbody cage with screws, plates, hooks and rods. Chapter 1 classes it by component: the cage class III, screws and plates class IIb, hooks class IIb on MDCG 2021-24 rev.1's reading, and rods, wires and pins open. As illustrative assumptions of this book, the company sells it in Germany and Italy under a certificate issued under one directive, Directive 93/42/EEC. It seeks its first MDR certificate under the Article 120 transition. Public hospitals buy it.

The table gives the position under the MDR certificate. Until then the implant is a legacy device, for which MDCG 2021-27 rev.1 reads Articles 13 and 14 with Article 120(3). In particular, the distributor's duties in Article 14(2), last subparagraph, and (4) to (6) apply. Verification of labelling and UDI requirements under the MDR does not. (MDCG 2021-27 rev.1, p. 8)

Our reading is that the duty to identify customers outlasts most distribution agreements, and that a tender bid is priced for the whole contract term, without counting on a later price increase. Where a distributor wins the tender, the company's price reconciliation ends at its own sell-in, the price the distributor pays it, as in the second computation in section 16.

As an illustrative assumption of this book, France is not yet entered. The company's first step there is the listing application that chapter 13 covers, and section 6 gives the French listing limit. The distributor's margin is assumed to pay for tender submissions, instrument sets and surgeon support.

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

The near-patient test measures cardiac troponin in blood, near the patient in hospital emergency departments. As illustrative assumptions of this book, the Swiss company has no Union entity and already sells the test through distributors in Germany, the Netherlands, Belgium and Austria. The test is a legacy device, placed on the Union market under a declaration of conformity drawn up under Directive 98/79/EC before 26 May 2022, with no notified body. Chapter 2 sets out the conditions for keeping it there.

The table gives the position once the test is certified under the IVDR. Until then, MDCG 2021-27 rev.1 reads Articles 13 and 14 with Article 110 for legacy devices. In particular, the importer's duties in Article 13(2), last subparagraph, (4), (6) to (8) and (10) apply. Verification of labelling and UDI requirements under the IVDR does not. (MDCG 2021-27 rev.1, p. 8)

Our reading is that a clause barring an importer from an unsolicited tender elsewhere restricts passive sales. Ratification of the EU-Switzerland package would reopen the analysis.

Reversal, on illustrative assumptions. Hospitals buy from the importers, so the company's transaction is its sell-in. The figures of the second computation in section 16 carry over: a hospital price of 820, 200 units a year, and a partner margin of 25 per cent on resale. A direct route through a Union subsidiary is assumed to need a team costing between 30,000 and 60,000 a year, with every other cost equal. The figures are scaled for visible arithmetic and are no benchmark.

Direct supply earns 200 times 820, which is 164,000, less the team cost. Through the partner, the company gives up 25 per cent of 164,000, which is 41,000, and pays for no team. The routes are equal where the partner margin times 164,000 equals the team cost.

At a team cost of 30,000, that margin is 18.3 per cent. At 60,000, it is 36.6 per cent. The partner's 25 per cent sits between the two, so direct supply wins at the low end and the partner at the high end. Which route is better therefore remains a hypothesis until the team cost is quoted, so the first wave of countries uses partners, which commit the company to no fixed team cost.

19. When specialist help is worth paying for#

• A partner will relabel, repackage or sell under its own name. Article 16 decides whether it becomes the manufacturer. (MDR Art. 16(1) to (4))
• An agreement grants exclusivity, restricts where a partner may sell, or sets a resale price floor. Whether the block exemption applies depends on the parties' market shares and on the kind of restriction. A post-term non-compete needs the Article 5(3) conditions. (Regulation 2022/720 Art. 3 to 5)
• The company appoints a commercial agent. The notice minima and the termination rules cannot be reduced to the agent's detriment. Whether the directive reaches a software licence or a partner that only introduces buyers is the first question for local counsel. (Directive 86/653 Art. 1(2), 15, 17 to 19)
• The company sells into Great Britain or Switzerland, each with its own registration and representative duties. (MHRA; MepV Art. 51, 55)
• A listed digital application enters German price negotiation, where the statutory floors on the agreement, the interim use of the manufacturer's actual price, and the arbitration deadlines affect the revenue forecast. (SGB V section 134)

Conclusion#

The national reimbursement route, the way a health insurer or health system pays for a device, decides who pays, and who pays decides which transaction the company has to price. On our reading, where a partner resells to a hospital, the hospital's price belongs to the partner's contract, and the company prices only its sell-in, what the partner pays it.

Each party's legal role under the EU Medical Device Regulation follows from what it does with the device, whatever the contract calls it. The form of contract decides which rules govern it: the EU directive protecting self-employed commercial agents may cover an agent, and EU competition rules cover a distributor. Competition law can still reach an agent that bears significant financial or commercial risk.

The company works out its price separately for each transaction. The reversal margin is the partner margin at which selling direct and selling through a partner give the same contribution, meaning revenue less the costs that differ between the two routes. It shows whether the choice of route holds at both ends of every input estimated as a range. A country's share of European device sales should weight the order of countries only once the route, the named key customers, and the roles are known.

The wearable heart monitor from a US company needs a sole authorised representative, one Union party appointed to act for it, whatever the channel. On the reading of MDCG 2021-27 rev.1, EU guidance on these roles, its Union subsidiary or Union partner is the importer, the business placing the monitors on the Union market. If its application will seek German statutory insurance cover, the company sets the Dutch application price with the German negotiation in view.

The AI triage software from a Union company has no importer. It is open whether the agency directive reaches a partner paid by commission, which on our reading decides whether the cost of ending that partnership, its notice period and any termination payment, enters the reversal margin.

The spinal implant sells through distributors to public hospitals. Its distributors must be able to identify the customers they supplied for at least 15 years, and on our reading its tender bids are priced for the whole contract term, without counting on a later price increase.

The near-patient cardiac troponin test from a Swiss company has an importer in each of its four Union markets. On illustrative assumptions, its break-even partner margin lies between 18.3 and 36.6 per cent, depending on what a direct team would cost. The partner's assumed 25 per cent falls inside that range, so the choice between direct and partner supply stays a hypothesis until the team cost is quoted.

Chapter 9 covers registration of the companies and the device, chapter 13 the national route, chapter 15 procurement, and chapter 17 the cost, dependency and funding plan built on these answers.