What will European market entry cost, what does it wait on, and who can pay?

Introduction#

A board that asks what Europe will cost and how long it will take needs three answers. The first is which work the company has to do, and in what order the law allows it. The second is what each piece of work costs, and what source each figure rests on. The third is which money can pay for each line of the plan, and what that money takes back, such as a share of ownership or a debt to repay.

The answers apply to medical devices under the Medical Device Regulation (MDR) and to in vitro diagnostic medical devices (IVDs), such as blood tests, under the In Vitro Diagnostic Medical Device Regulation (IVDR). They cover software too, and companies based both inside and outside the EU.

The chapter follows four illustrative composites. The first is a wearable cardiac monitor from a United States company with no establishment in the EU. It therefore needs an authorised representative, a person in the EU who acts for it under a written mandate. The second is triage software enabled by artificial intelligence (AI), from a German company. It is planned as class IIb, the second-highest of the MDR's risk classes, and also falls under the Artificial Intelligence Act (AI Act).

The third is a spinal implant, CE marked under the older Directive 93/42/EEC, that now seeks its first certificate under the MDR. The fourth is a cardiac troponin blood test used near the patient in hospital, from a Swiss company that sells through distributors. The sources were checked on 30 September 2026.

1. What does a notified body charge, and how is the price quoted?#

Under the MDR, a notified body is a conformity assessment body designated under that Regulation. Conformity assessment is the process of demonstrating whether a device fulfils the Regulation's requirements. (MDR Art. 2(40), 2(42))

Notified bodies have to establish lists of their standard fees for the conformity assessment activities they carry out, and make those lists publicly available. The same duty applies under the IVDR. A body has to operate on consistent, fair and reasonable terms, taking into account, in relation to fees, the interests of each small and medium-sized enterprise (SME). The Commission publishes a page of links to the fee lists on the bodies' own websites. (MDR Art. 50; Annex VII s. 1.2.8; IVDR Art. 46; Annex VII s. 1.2.8; Commission fee-list directory)

What the guidance used here is worth#

The documents of the Medical Device Coordination Group (MDCG) used here are guidance. So are the Commission's question-and-answer paper on Regulation 2023/607 and the work programme of the Member State Coordination Group on Health Technology Assessment (the Coordination Group), set up by the health technology assessment (HTA) Regulation. Each carries a disclaimer on its first page, and MDCG guidance records how the Member States' representatives read the regulations. Only the Court of Justice of the European Union gives binding interpretations. (HTA Regulation Art. 3(1); MDCG 2023-2, p. 1)

What a fee list shows#

MDCG 2023-2 interprets "publicly available" to mean direct and easy access on the website registered for the body in NANDO, without registering or giving contact data. NANDO, short for New Approach Notified and Designated Organisations, is the database of notified bodies that the Commission develops and manages. (MDCG 2023-2, introduction; MDR Art. 42(2))

The same guidance says fees can be flat or time-based, or a range together with the factors that decide where in the range a fee falls, and that justified external costs such as travel should be claimed as expenditure. Its template lists fee items running from the application fee and annual maintenance to audits and assessments of documentation and changes. (MDCG 2023-2, scope and explanation; MDR template)

SME treatment differs from list to list. As a dated example, the list of notified body 0050, effective 11 November 2024, reduces estimated costs for audit-related activities for small and micro enterprises. The Commission's directory links to each body's current list. (Notified body 0050 fee list; Commission fee-list directory)

What a quotation contains under the 2026 Regulation#

Implementing Regulation (EU) 2026/977 adds rules on quotations. Before quoting, the body needs the manufacturer's headcount and turnover, from which it determines whether the manufacturer is a micro, small or medium-sized enterprise. It also needs each device's intended purpose, risk class and conformity assessment procedure, and anything else needed to estimate the work. (Reg. 2026/977 Art. 1(1))

(Reg. 2026/977 Art. 1(3), (4))

The Regulation applies from 25 February 2027. As a dated example, its Articles 1 to 3 do not apply where the written agreement was signed before 25 February 2027. Article 4(1) to (3) applies to agreements signed after 25 May 2027. The provision on the annual report applies from 1 January 2028. Articles 8 and 9 of the Official Journal text govern these dates. (Reg. 2026/977 Art. 8, 9)

2. In what order does the law put the first steps?#

Before placing a device other than a custom-made device on the market, the manufacturer, the authorised representative and the importer register in the European database on medical devices (EUDAMED). Where a notified body is involved under Article 52, that registration information goes into the system before the application to the body. IVDR Article 28(1) sets the same order for IVDs. (MDR Art. 31(1); IVDR Art. 28(1))

An authorised representative is a person established in the Union who has accepted a written mandate from a manufacturer outside the Union to act for it on specified tasks. Such a manufacturer may place a device on the Union market only if it designates a sole authorised representative. The mandate has to cover the Article 31 registration obligations, and the task of checking that the manufacturer has met its own obligations under Articles 27 and 29. (MDR Art. 2(32), 11(1), 11(3); IVDR Art. 11(1))

Our reading is that, for a manufacturer outside the Union, the authorised representative's mandate is the first step, ahead of registration.

In the unique device identification (UDI) system, the Basic UDI-DI is the primary identifier of a device model. It is the device identifier (DI) assigned at the level of the device unit of use, and the main key for records in the UDI database. (MDR Annex VI, Part C, s. 1)

Before placing a device other than a custom-made device on the market, the manufacturer also assigns a Basic UDI-DI and provides it to the UDI database with the other core data. For the routes in Article 52(3) and the second and third subparagraphs of Article 52(4), it is assigned before the manufacturer applies to a notified body. (MDR Art. 29(1), 29(3))

The application is a formal document signed by the manufacturer or its authorised representative. The contract that follows is a written agreement signed by both parties. Registration therefore comes first, then the application, then the written agreement. Where Implementing Regulation (EU) 2026/977 applies to the agreement, the audit and the product verification start the day after it is signed unless the parties agree otherwise. (MDR Annex VII s. 4.3; Reg. 2026/977 Art. 2(2), 8)

For implantable and class III devices, other than custom-made or investigational devices, the manufacturer drafts a summary of safety and clinical performance, which the notified body validates and uploads to EUDAMED. Under the IVDR, class C and D devices, other than devices for performance studies, likewise need a summary of safety and performance. (MDR Art. 32(1); IVDR Art. 29(1))

When the EUDAMED obligations start#

Commission Decision (EU) 2025/2371, published on 27 November 2025, confirmed four EUDAMED systems as functional, including actor registration and the UDI database with device registration. The obligations relating to a system, including those in MDR Articles 29, 31 and 32 and IVDR Articles 26, 28 and 29, apply from six months after the notice that the system is functional is published. For these four systems, the six months run from the Decision's publication in the Official Journal. (Decision (EU) 2025/2371, Art. 1, 2; MDR Art. 123(3)(d); IVDR Art. 113(3)(f))

No later than 12 months from the Decision's publication, manufacturers have to ensure the Article 29 information is entered. That includes devices placed on the market under Article 120(3), (3a) or (3b) and not already registered, provided they are still placed on the market from six months after publication. (MDR Art. 123(3)(e))

3. How long may the notified body take?#

Implementing Regulation (EU) 2026/977 sets four maximum timelines for a conformity assessment. On the Annex IX route, conformity assessment based on a quality management system and on assessment of technical documentation, they are as follows.

(Reg. 2026/977 Art. 2(2); MDR Annex IX)

The audit and the product verification may run in parallel only if the required input from the technical documentation assessment is taken into account when the audit programme is developed. (Reg. 2026/977 Art. 2(2))

By our computation, on the Annex IX route with that condition met, the periods add up as 30 days, then the longer of the 120-day audit and the 90-day verification, then 20 days. That is 170 days, of which 140 fall after the agreement is signed. Both figures are upper limits on the periods the body may count, and apply only where the Regulation applies to the agreement.

The body may interrupt the timeline where the manufacturer has to address non-compliances or answer justified questions. It may do so once at application review, four times each at the audit and the product verification, and once at decision to have the certificate details checked. Each additional site audited on-site adds two interruptions to the audit phase. (Reg. 2026/977 Art. 3(1))

An interruption stops the timeline on the day the body says what it needs. Unless otherwise agreed, the timeline resumes the day after the body receives the information. Interruptions for an opinion of the European Medicines Agency (EMA), a regulatory authority, an expert panel or an EU reference laboratory are not counted with the others. (Reg. 2026/977 Art. 3(2), (3))

Expiry of a maximum timeline, or use of every interruption, is not a sufficient reason for the body to refuse a certificate. Our reading is that 170 days bounds the body's working periods and does not predict a certificate date. (Reg. 2026/977 Art. 2(4))

Separate maximum timelines apply to changes and to re-certification. A planned substantial change has 30 days for review, 90 for any additional assessment and 20 to issue the certificate supplement. On re-certification, the body assesses the documentation for a product certificate within 90 days of receipt, and acts on a quality management system certificate within 90 days of the application. The decision and re-issue have their own 20 days. (Reg. 2026/977 Art. 2(3), 5(4), 6(1), 7(2))

What bodies have reported#

The 20th notified body survey, with data at 28 February 2026, found that in 65 per cent of MDR cases it took less than 2 months from application lodged to written agreement. Under the IVDR, from 19 bodies, the figure was 68 per cent. (20th notified body survey, slides 27 and 54)

From signed agreement to a new MDR certificate, 62 per cent of bodies took 13 to 18 months for a quality management system certificate. For one that also covers the product, 51 per cent took 13 to 18 months. The shares are of bodies that had issued such certificates; the survey's notes give data from 47 and 39 bodies respectively, and say that 5 and 13 bodies had issued none yet. (20th notified body survey, slides 30 and 55)

The data predate the Regulation's publication on 5 May 2026. Our reading is that the survey's bands record the total time elapsed after the agreement, while the 170-day ceiling limits only the periods the body may count. On the same reading, the time spent finding a body falls before either of the periods the survey measures.

4. Which costs recur after launch?#

The quality management system has to be maintained, kept up to date and continually improved, except for investigational devices and devices for performance studies. The post-market surveillance system is part of it. (MDR Art. 10(9), 83(1); IVDR Art. 10(8))

(MDR Art. 31(4), (5), 86(1), 87(3) to (5); IVDR Art. 81(1), 82(3) to (5))

MDCG 2022-21 says the PSUR data collection period should start at the device's certification date under the MDR. For a device without an MDR certificate, it starts the period at the MDR's date of application, 26 May 2021. For class III and implantable devices, it says the PSUR should go through EUDAMED to the notified body. (MDCG 2022-21, s. 5.1, 5.2)

The EUDAMED system for vigilance and post-market surveillance is not among the four declared functional. The Commission declares a system functional by a notice, as Decision (EU) 2025/2371 did for those four. (MDR Art. 33(2)(f); Decision (EU) 2025/2371, Art. 1)

Our reading is that, for a newly certified device, the date of the first PSUR follows from the certification date and the post-market surveillance plan, and cannot be worked out from the month of launch. A legacy device is in a different position, because Article 120(3d) applies the MDR's post-market surveillance requirements to it in place of the directives' requirements, so on the same reading its PSURs are already due. (MDR Art. 120(3d))

Two standing costs follow. The manufacturer needs a person responsible for regulatory compliance within its organisation, or, for micro and small enterprises, permanently and continuously at its disposal. It also needs cover for potential liability for defective devices, proportionate to the risk class, the device and the size of the enterprise. (MDR Art. 10(16), 15(1), (2); IVDR Art. 10(15), 15(1), (2))

Chapter 11 covers the post-market work itself.

5. Which dates are set by others?#

Legacy devices. A legacy device here is one placed on the market under the transitional provisions of MDR Article 120.

A device certified under Directive 90/385/EEC or 93/42/EEC may still be placed on the market under the Article's conditions, until a date set by risk class. As a dated example, the consolidated text checked gives 31 December 2027 for class III devices and most class IIb implantables, and 31 December 2028 for other class IIb devices. The conditions include a formal application by 26 May 2024 and a written agreement by 26 September 2024. (MDR Art. 120(3a), (3c))

The Commission's question-and-answer paper on Regulation 2023/607 says that withdrawing the application or ending the agreement after the deadlines ends the transition. It also says that where, at the same time, the manufacturer signs a written agreement with another body and the application is transferred to that body, the conditions are considered still met, provided the other conditions are met. (Q&A on Regulation 2023/607, question 9.1)

IVDs that newly need a notified body have their own dates and application deadlines by class. As a dated example, a class C device whose declaration under Directive 98/79/EC was drawn up before 26 May 2022, without a notified body, may be placed on the market until 31 December 2028. (IVDR Art. 110(3b))

That holds only if the Article 110(3c) conditions are met, including a formal application by 26 May 2026 and a written agreement by 26 September 2026. Article 110(3b) of the consolidated IVDR gives the dates for the other classes. (IVDR Art. 110(3c))

AI-enabled devices. Under the AI Act, an AI system that is a device, or a safety component of one, is high-risk where the MDR or IVDR requires a third-party conformity assessment. Chapter 10 sets out when the high-risk requirements apply. (AI Act Art. 6(1); Annex I, Section A)

The AI Act requirements become part of the MDR or IVDR assessment. Bodies notified under those Regulations may assess them under the conditions of Article 43(3), and have to apply for AI Act designation by 28 January 2028. (AI Act Art. 43(3))

Union HTA. Joint clinical assessment compares the available clinical evidence on a technology with other technologies or existing procedures. It reaches selected class IIb and III devices for which the expert panels have given a scientific opinion in the MDR Article 54 clinical evaluation consultation procedure. It also reaches selected class D IVDs for which they have given views under IVDR Article 48(6). (HTA Regulation Art. 2(6), 7(1))

Article 54 applies to class III implantable devices and to class IIb active devices intended to administer or remove a medicinal product under Rule 12. Article 54(2) disapplies the procedure in listed cases, such as the renewal of a certificate issued under the MDR. (MDR Art. 54)

In a joint scientific consultation (JSC), the Coordination Group exchanges information with developers on their development plans, to help generate evidence for a later joint clinical assessment. A technology is eligible where it is likely to be the subject of joint clinical assessment under Article 7(1) and its clinical studies and investigations are still in the planning stage. (HTA Regulation Art. 16(1), (2))

Our reading is that a device outside the Article 54(1) categories, and outside class D, fails the first eligibility condition, that the technology is likely to be the subject of joint clinical assessment.

Requests for a JSC can be made only in published request periods. By 30 November each year the Coordination Group sets at least three request periods for the next year. The 2026 work programme set four, and each request is followed by a briefing package. (Commission JSC page; Reg. 2025/117 Art. 2, 3, 8; HTA work programme 2026, s. 4)

Consultations were offered without fees in 2026. Chapter 12 covers the HTA gate. (HTA work programme 2026, s. 1)

German hospital payment. In Germany's new-methods (NUB) procedure, the hospitals make the requests. As a dated example, hospitals that asked by 31 October 2025 received the answer for 2026 on 31 January 2026 from the Institut für das Entgeltsystem im Krankenhaus (InEK), which replies to the requests. (InEK explanation for 2026, first paragraph)

Status 1 permits a hospital-specific payment for that year. Status 2 means the method does not meet the criteria of the NUB agreement, and a hospital-specific payment for 2026 is not permitted on that basis. (InEK explanation for 2026, Status 1 and 2)

InEK's yearly explanation gives each year's dates.

Public tenders. The Procurement Directive sets rules for procurement by contracting authorities, meaning State, regional or local authorities, bodies governed by public law and their associations. It reaches contracts whose estimated value is not less than its Article 4 thresholds. As a dated example, the consolidated text checked sets EUR 216,000 for supply contracts of sub-central authorities. (Procurement Directive Art. 1(1), 2(1)(1), 4)

Within that scope, any interested economic operator may submit a tender in an open procedure, and the minimum time limit for tenders is 35 days from the date the contract notice is sent. (Procurement Directive Art. 27(1))

The limit can fall to 15 days where a prior information notice meeting the listed conditions was sent 35 days to 12 months before the contract notice. It falls by five days where tenders are accepted electronically, and to not less than 15 days in duly substantiated urgency. (Procurement Directive Art. 27, 48(1))

Our reading is that where the buyer is not a contracting authority, or the contract is below the thresholds, the buyer's own rules and the period stated in its notice govern the tender.

A framework agreement, in the Directive's sense, sets the terms for contracts awarded during a given period, and runs no longer than four years, save in exceptional cases duly justified. A decision not to divide a contract into lots needs its main reasons stated. Chapter 15 covers the procedure and how to tell which rules apply. (Procurement Directive Art. 33(1), 46(1))

6. Which public money can pay, and on what tests?#

Public money arrives as grants, loans, prizes and equity, which differ in what the company gives back.

(ZIM guideline, Nr. 5.2.1; Pro FIT project financing page; EIT Health Catapult page; EIC Accelerator page; HTGF investment criteria)

Each scheme applies its own tests, and a company can pass one scheme's test and fail the next.

(ZIM guideline, Nr. 3.1.1; HTGF investment criteria; EIC Accelerator page; Pro FIT project financing page; EIC Work Programme 2026; Bourse French Tech page)

ZIM's market introduction services are tied to a funded ZIM R&D project. As a dated example, they include innovation support services, which the guideline lists as including testing and certification, as well as trade fairs and marketing advice. They can be sought up to 18 months after the project succeeds, at 50 per cent of eligible costs up to EUR 100,000 per funded project, which by our computation caps the aid at EUR 50,000. Whether notified-body fees qualify as eligible costs has to be confirmed with the programme. (ZIM guideline, Nr. 2.3, 4.4, 5.2.4 and 5.4.4)

The de minimis ceiling#

De minimis aid stays under a fixed amount over a specific period, and is not subject to the State aid notification procedure. The total granted per Member State to a single undertaking cannot exceed EUR 300,000 over any period of 3 years. A single undertaking includes enterprises linked by majority voting rights, the right to appoint a majority of the board, or a dominant influence by contract. (De minimis Reg. recital 1; Art. 2(2), 3(2))

Aid is deemed granted when the legal right to it is conferred, whatever the payment date. Pro FIT's market-phase loans and ZIM's market introduction services are granted as de minimis aid. (De minimis Reg. Art. 3(3); Pro FIT project financing page; ZIM guideline, Nr. 2.3)

Who counts as an SME#

MDR Article 15(2) and the 2026 Regulation's Article 1(1) apply the SME definition in Recommendation 2003/361/EC. It sets fewer than 250 staff, with turnover up to EUR 50 million or a balance sheet up to EUR 43 million. (MDR Art. 15(2); Reg. 2026/977 Art. 1(1); Recommendation 2003/361/EC, Annex, Art. 2)

An enterprise holding 25 per cent or more of the capital or voting rights of another, without being linked to it, is its partner enterprise. Venture capital companies, and business angels investing less than EUR 1,250,000 in total in the same enterprise, can hold that share without becoming partners, provided they are not linked. (Recommendation 2003/361/EC, Annex, Art. 3(2))

Figure 17.3 also shows EIC Pathfinder grants at readiness levels 1 to 4, Pro FIT early-phase financing for Berlin companies up to 12 months old, and the Dutch Innovatiekrediet, which its page calls a credit. (EIC Pathfinder; Pro FIT early phase; Innovatiekrediet)

7. How the answer is reached#

The entry plan is built as a model with one line per work package. Each line records its basis, what it depends on, its timing, its behaviour, its cost basis with a grade, and its funding source. Each step below takes the previous one as its input:

1. The work packages come from the product's class, route and role, which chapter 1 sets out, and from the chosen notified body. They run from the mandate and registration to the assessment and the post-launch reports, with commercial packages such as tenders after them.
2. Each line's basis is an instrument, guidance, a contract or commercial practice, and a line with no basis is labelled as an assumption.
3. The dependencies are set before any durations are estimated: the legal order from section 2, then every conditional dependency with its condition stated.
4. The notified-body timeline is counted from the complete application and then from the written agreement, and the 170-day ceiling is used only where section 3 says it applies. The time before the written agreement, and the effect of interruptions, are entered as ranges that the chosen body gives.
5. The notified-body cost starts from published rates, each with its unit and effective date, and the body's quotation converts them into a cost estimate. Other lines are company estimates with a stated assumption, and a missing benchmark shows as a gap.
6. The recurring lines from section 4 run for the whole period the model covers, with surveillance and unannounced audits from the quotation.
7. Funding is tested line by line against each scheme's own dated wording. Each award is counted against the de minimis ceiling for the whole single undertaking in each Member State. (De minimis Reg. Art. 2(2), 3(2))
8. The financing gap is the sum of the cost ranges by quarter, less contracted funding. A competitive award appears only in a scenario and counts as zero in the base case. Equity costs a share of ownership, a loan carries a liability, and a grant carries conditions.

Our reading is that each line shows one or more of five behaviours, and the behaviour determines what spending money on that line can change.

(MDR Art. 31(1), 120(3a); 20th notified body survey; InEK explanation for 2026)

Each figure is graded as published, quoted, company estimate or illustrative assumption, with its date or assumption. Each line holds its own range, and a programme contingency is held centrally.

8. The four running cases#

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

The monitor's hardware is class IIa under Rule 10, on our reading. Its companion application, which runs on the patient's phone, 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 planning assumption is that it records only.

The company is already cleared and selling in the United States, and, as an illustrative assumption, enters Germany and the Netherlands first.

Order. The company is not established in a Member State, so it needs a sole authorised representative before the monitor is placed on the Union market. A notified body is involved, so registration goes into EUDAMED before the application. Our reading is that the mandate and the registration are the first two lines, ahead of any quotation. (MDR Art. 11(1), 31(1))

At class IIa, both the hardware and the application are assessed under Article 52(6), which is not among the routes for which Article 29(3) requires the Basic UDI-DI before the application to the body. On our reading the Basic UDI-DI is still due before the monitor is placed on the market, and may be assigned after the application, so the plan need not put it ahead of the application. (MDR Art. 29(3), 52(6))

Clock and cost. Suppose, as an illustrative assumption, that the company uses Annex IX and signs its agreement on a date to which the Regulation applies. The periods its body may count are then capped at 170 days. The quotation follows once the body has the company's headcount and turnover. In deciding SME status, the data of partner enterprises are added in proportion to their holding. (Reg. 2026/977 Art. 1(1), 2(2), 8; Recommendation 2003/361/EC, Annex, Art. 3(2), 6(2))

Funding. Third-country applicants to the EIC Accelerator may relocate before the full application. ZIM looks for a permanent establishment or branch in Germany at the time or during the period of payment. HTGF accepts a German base of operations, and Innosuisse needs Swiss headquarters and an entry in the Swiss commercial register. Our reading is that the company's decision on whether and where to set up a European entity, which chapter 16 covers, decides which of these schemes are open to it. (EIC Accelerator page; ZIM guideline, Nr. 3.1.1; HTGF investment criteria; Innosuisse start-up projects page)

(MDR Art. 11(1), 31(1), 123(3)(d); Reg. 2026/977 Art. 1(3), 2(2))

The money, worked. Suppose, as an illustrative assumption, the euro ranges below for the European lines over four quarters. The quarters follow the assessment stages in section 3.

Contracted funding in the base case is zero, because the EIC award sits in a scenario and nothing else is signed. By our computation the gap therefore equals the sum, EUR 135,000 to 230,000.

Suppose, as a further illustrative assumption, that a one-year loan at 8 per cent covers the gap at the high end of the range. By our computation it costs EUR 18,400 in interest and leaves EUR 230,000 to repay. Equity could cover the same gap instead, at the cost of a share of ownership.

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

The triage tool is AI-enabled software that suggests how soon each patient should be seen, and the triage nurse confirms or changes the suggestion. Class IIa to III are all arguable under Rule 11, and the tool is planned as class IIb. Its maker's home Member State is Germany.

AI Act. The tool is a high-risk AI system through Annex I, and chapter 10 gives the dates that reach it. Its notified body has to apply for AI Act designation by 28 January 2028, so the model carries a line for confirming that the body will be designated to assess the AI Act requirements, with a second body as a fallback. (AI Act Art. 6(1), 43(3); Annex I, Section A)

HTA. Joint clinical assessment reaches a selected class IIb or III device where the expert panels have given an opinion under Article 54, whose categories section 5 sets out. Our reading is that the tool is outside joint clinical assessment and JSC eligibility at each arguable class, so the question of how the AI-related selection criterion in Article 7(4) applies does not arise on the current record. That holds until a change of product or purpose brings it within Article 54(1). (HTA Regulation Art. 7(1), 7(4), 16(2); MDR Art. 54(1))

Funding. The EIC Accelerator grant is a lump sum below EUR 2.5 million for work at readiness levels 6 to 8, given once in the Horizon Europe period. A blended award's decision takes 2 to 6 months, and on our reading the model includes the award only in a scenario. (EIC Accelerator page; EIC Work Programme 2026)

If, as a further illustrative assumption, the company's German seat is in Berlin, Pro FIT funds experimental development by loan for SMEs. Our reading is that most of the tool's remaining work is development. (Pro FIT project financing page)

(AI Act Art. 43(3), 113(c); MDR Art. 54(1); EIC Work Programme 2026; Pro FIT project financing page)

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

The implant is a spinal implant system, CE marked under Directive 93/42/EEC as a non-active implant and seeking its first MDR certificate. Its class differs by component. The cage is class III, the screws and plates class IIb, and the hooks class IIb on the reading in MDCG 2021-24 rev.1. The rods, wires and pins are open, because Rule 8 does not name them.

Clock. The Article 120 conditions required a formal application by 26 May 2024 and a written agreement by 26 September 2024. Suppose, as an illustrative assumption, that the company met both in 2024. (MDR Art. 120(3c))

As dated examples, Article 120(3a) then lets the class III cage stay on the market until 31 December 2027, and the screws and plates, which point (a) excepts, until 31 December 2028. Articles 1 to 3 of the 2026 Regulation do not apply to an agreement signed before 25 February 2027. (MDR Art. 120(3a); Reg. 2026/977 Art. 8(1))

Our reading is that, under that assumed agreement, the 170-day ceiling does not apply to the implant's assessment, and its timeline comes from the body's quotation and contract.

If the company changes notified body, the device keeps its transitional status only on the terms of the Commission's question-and-answer paper set out in section 5. (Q&A on Regulation 2023/607, question 9.1)

A new agreement signed on or after 25 February 2027 may fall within Articles 1 to 3. The re-certification articles do not apply to certificates expiring before 25 November 2027. (Reg. 2026/977 Art. 5(4), 7(2), 8)

Funding. ZIM funds R&D projects, Pro FIT's grant phase is industrial research, and HTGF's age limit is three years. Our reading is that a first MDR certificate for an unchanged device fits these tests poorly, so the model funds it from own cash and legacy revenue. (ZIM guideline, Nr. 5.2.1; Pro FIT project financing page; HTGF investment criteria)

HTA. Class III implantable devices fall within MDR Article 54(1), unless an Article 54(2) exception applies, so the cage does and the non-active class IIb components do not. After an expert panel opinion the cage may be selected for joint clinical assessment, and it is eligible for a JSC where its clinical investigations are still in the planning stage. Our reading is that a JSC line belongs here if the company plans a new investigation. (MDR Art. 54; HTA Regulation Art. 7(1), 16(2))

(MDR Art. 32(1), 86(1), 120(3d), 123(3)(e); MDCG 2022-21, s. 5.1; Reg. 2025/117 Art. 2, 8(3))

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, on an analyser the same company supplies. The Swiss company has no Union entity and sells into Germany, the Netherlands, Belgium and Austria through distributors.

Serial measurement is class C under Rule 3(j), and single measurement class B under Rule 6 on the guidance's contested reading. Both purposes are planned as class C until a notified body confirms otherwise, and the case follows the serial purpose.

Fixed lines. The test is a legacy device, sold under a declaration drawn up under Directive 98/79/EC before 26 May 2022, without a notified body. Article 110(3b)(b) lets it stay on the market until 31 December 2028, as a dated example, only if the Article 110(3c) conditions are met. At class B the date would be 31 December 2029. (IVDR Art. 110(3b), (3c))

The conditions include a quality management system by 26 May 2025, a formal application by 26 May 2026 and a written agreement by 26 September 2026. Suppose, as a further illustrative assumption, that the company met all three. (IVDR Art. 110(3c))

Our reading is that the agreement then predates 25 February 2027, so Articles 1 to 3 of the 2026 Regulation do not apply to it, and the assessment timeline comes from the body's contract. A test that missed either deadline cannot rely on Article 110(3b). (Reg. 2026/977 Art. 8(1))

Order and clock. The company needs a sole authorised representative, and registration information goes into EUDAMED before an application, under provisions that apply six months after the EUDAMED notice. The Regulation's maximum timelines cover IVDR assessments where it applies to the agreement. (IVDR Art. 11(1), 28(1), 113(3)(f); Reg. 2026/977 Art. 2(2))

HTA. Joint clinical assessment can reach class D IVDs with expert panel views, if they are selected, so at class C the test is outside that gate until the class moves to D. (HTA Regulation Art. 7(1)(d))

Tenders. Where the hospital buyer is a contracting authority and the contract reaches the thresholds, the minimum tender periods in section 5 apply. On our reading, work on the response starts before any notice appears, and the length of a framework agreement and its division into lots determine how much business a lost tender costs the company. (Procurement Directive Art. 1(1), 4, 27, 33(1), 46(1))

Funding. Suppose, as an illustrative assumption, that the company is four years old with 30 full-time staff. It then meets Innosuisse's age and size tests, and Innosuisse covers at most 70 per cent of direct project costs. The project also has to rest on application-oriented research and prepare a first market entry, and the page does not say whether conformity assessment fees are eligible. (Innosuisse start-up projects page)

Our reading is that a company already selling through distributors may fail the requirement that the project prepare a first market entry, so the model funds the notified-body assessment from own cash.

(IVDR Art. 110(3b), (3c); Reg. 2026/977 Art. 1(3), 8; Procurement Directive Art. 1(1), 4, 27)

9. When specialist help is worth paying for#

• A legacy device is near its transition date, or a change of notified body is planned. Our reading is that the conditions leave little room for error. (MDR Art. 120(3c); Q&A on Regulation 2023/607, question 9.1)
• Aid will come from several Member States, or through several group companies. The ceiling counts the single undertaking in each Member State, and cumulation has limits. (De minimis Reg. Art. 2(2), 3(2), 5(3))
• Market-entry spending might count as export-related, which the de minimis Regulation excludes. (De minimis Reg. Art. 1(1))
• The body for an AI-enabled device has not confirmed AI Act scope. The designation deadline and the conditions sit in Article 43(3). (AI Act Art. 43(3))

Conclusion#

The three answers depend on one another. The device's risk class, its conformity assessment route (how it shows it meets the law) and the company's legal role decide which pieces of work the plan contains. Where a notified body (an independent assessor) is involved, the law fixes part of their order. The company registers in EUDAMED, the EU database, before it applies to the body, and applies before it signs the written agreement.

Where Implementing Regulation (EU) 2026/977 applies to that agreement, its maximum periods limit the time the notified body may count, and the count pauses whenever the body interrupts it, for example while the company answers a question. The body's quotation converts its published fees into a cost estimate. Each funding scheme applies its own eligibility tests, and the plan's base case counts an uncontracted competitive award as zero.

For the wearable cardiac monitor from a US company, the first two steps on our reading, ahead of any quotation, are a mandate to an authorised representative, a person in the EU who acts for it, and then registration in EUDAMED. If, as an illustrative assumption, it uses Annex IX and signs once the Regulation applies to its agreement, the body's counted time is capped at 170 days. On our reading, whether and where it sets up a European entity decides which of the schemes reviewed are open to it.

The AI triage software from a German company needs a notified body that is also designated to assess the AI Act requirements, and bodies have to apply for that designation by 28 January 2028. Its plan therefore carries a line confirming it, with a second body as fallback.

The spinal implant seeks its first MDR certificate under an agreement assumed signed in 2024, so on our reading the 170-day ceiling does not apply and its timeline comes from the body's quotation and contract. On the same reading, the schemes reviewed fit an unchanged device poorly, so own cash and existing sales fund it.

Joint clinical assessment, the EU-level comparison of clinical evidence, does not reach the Swiss cardiac troponin test at class C. On our reading, the company may fail the Swiss Innosuisse scheme's first-market-entry test because it already sells through distributors, so own cash funds its assessment.

Chapter 18 audits an entry programme model of this kind. Chapter 1 covers scope and roles, chapter 8 the notified body, chapter 9 registration, chapter 10 the AI Act, chapter 11 post-market work, chapter 12 Union HTA, chapter 13 the national route, chapter 15 procurement and chapter 16 the European entity.