# Which commitments in the entry programme should be checked before options close?

## Introduction

A company entering the European Union (EU) market makes commitments that are hard to undo. One is the application to a notified body, the independent organisation that assesses a device, where the law requires it, before it can carry the CE mark. Others are a signed agreement, first placing on the market (the first supply of the device in the EU), a national filing, and a tender. Each rests on a reading of a rule. Before the step is taken, changing that reading costs only a conversation. After it, the company has fewer ways to change course, so the time to test each reading is before the commitment.

This chapter sets out thirteen checks on those commitments. Each names the rule or guidance it rests on and the event after which the company's options narrow. The first checks cover the notified body, the European database on medical devices (EUDAMED), where devices and companies are registered, and the Artificial Intelligence Act (AI Act). Later ones cover Union health technology assessment (HTA), the EU's joint work on assessing the clinical evidence for health technologies, then tenders and relationships with clinicians.

The checks are applied to four illustrative products used in every chapter. The wearable cardiac monitor comes from a United States (US) company with no Union establishment. The triage software enabled by artificial intelligence (AI) comes from a German company. The spinal implant system, CE marked under Directive 93/42/EEC, the law the Medical Device Regulation (MDR) replaced, seeks its first certificate under the MDR. The near-patient test for cardiac troponin, used in hospital emergency departments and governed by the In Vitro Diagnostic Medical Device Regulation (IVDR), comes from a Swiss company. The sources were checked on 29 and 30 September 2026.

## In short

A notified body, the independent organisation that assesses the device, may not act as a consultant on a device it assesses, though it may exchange technical information and regulatory guidance with the applicant. On our reading, whether a question stays on the permitted side depends on its subject, its context, and the stage of the assessment, as well as its wording. Asking what a requirement means is guidance. Asking the body to review a draft clinical evaluation, the report on the device's clinical evidence, before applying asks it to assess. A manufacturer may not apply to a second notified body in parallel for the same procedure, so on our reading the choice of body narrows once the application is lodged. ([MDR Annex VII s. 1.2.3, 1.2.9; Art. 53(1)][MDR])

Before placing a device on the market, the manufacturer assigns the primary identifier of the device model (the Basic UDI-DI) and enters the registration data in EUDAMED, the EU's database on medical devices, subject to transitional periods. Registration therefore belongs before launch in the plan. Where a EUDAMED module is not yet mandatory, the information still passes through the routes of the earlier Directives, the laws the MDR and the IVDR replaced. Guidance from the Medical Device Coordination Group (MDCG), of national regulators chaired by the Commission, takes the view that the MDR requirements in those deferred provisions already apply. On our reading, which follows that guidance for the MDR, the company meets those requirements now, using the older routes only to send information. ([MDR Art. 29(1), (4), 123(3)][MDR]; [IVDR Art. 26(1), (3), 113(3)][IVDR]; [MDCG 2021-1 Rev.1, pp. 3 and 4][MDCG 2021-1])

Several steps in the programme are open only if conditions are met. Joint clinical assessment is the EU-level comparison of a device's clinical evidence. A device reaches it only if an EU expert panel of clinical specialists has given a scientific opinion or views on it and it is then selected. In Germany, the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) describes the statuses of new examination and treatment methods (NUB). On its page, Status 2, given in reply to a hospital's request for a separate fee, means a hospital-specific fee may not be agreed for that request, so a forecast cannot count on it. A device still relying on a certificate issued under the earlier Directives may be placed on the market during the MDR's transition period, which runs to the Article 120(3a) date, only if five conditions are met. They include an MDR quality management system and a signed agreement with a notified body, each by a deadline. ([HTA Regulation Art. 7][HTAR]; [GKV-Spitzenverband NUB page][GKV NUB]; [MDR Art. 120(3a), (3c)][MDR])

## 1. What is checked, and when?

An entry programme is the set of work packages, dependencies, owners and dates that takes a device from development to paid use. Chapter 17 builds it as the entry programme model, and the checks examine that model together with the documents behind it.

The checks apply to medical devices under Regulation (EU) 2017/745 (the MDR) and in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (the IVDR), including software. They apply to companies inside and outside the Union. Devices fall into classes I, IIa, IIb and III by intended purpose and inherent risk, and IVDs into classes A, B, C and D. ([MDR Art. 51(1)][MDR]; [IVDR Art. 47(1)][IVDR])

A notified body is a conformity assessment body designated under the MDR or the IVDR. Placing on the market is the first making available of a device, other than an investigational device, on the Union market. ([MDR Art. 2(28), 2(42)][MDR]; [IVDR Art. 2(34)][IVDR])

Our observation, the label for what we have seen in advisory practice, is that the patterns behind the checks recur in entry programmes. We have found no published count of them, so they carry no ranking and appear in programme order. Most patterns leave a mark in the company's own documents before the commitment is made, and we call that mark the tell. A tell raises a question without settling it, because each tell also has an innocent explanation.

**Figure 18.1. Where each option narrows across the programme.**

![Figure 18.1: thirteen checks, placed at the programme event after which each option narrows](figures/figure-18-1-where-options-narrow.svg)



### What the guidance behind several checks is worth

The MDCG is made up of members each Member State appoints to represent its competent authorities, and a representative of the Commission chairs it. A competent authority is the national regulator that implements the MDR. ([MDR Art. 101, 103(2), (5)][MDR])

MDCG 2019-6 Rev.5 and MDCG 2021-1 Rev.1 state on their covers that their views are not legally binding. MDCG 2019-6 Rev.5 adds that only the Court of Justice of the European Union can give binding interpretations of Union law. The guidance on selecting devices from the Member State Coordination Group on Health Technology Assessment (the Coordination Group) says the same of itself, and adds that the Commission has not endorsed it. ([MDCG 2019-6 Rev.5, cover page][MDCG 2019-6]; [MDCG 2021-1 Rev.1, cover page][MDCG 2021-1]; [Coordination Group selection guidance V2.1, cover page][HTACG selection])

## 2. Check 1: What may a notified body discuss before and during assessment?

A notified body and its assessment staff may not provide consultancy services to the manufacturer on the design, construction, marketing or maintenance of the devices or processes under assessment. Exchanges of technical information and regulatory guidance with a manufacturer applying for conformity assessment are not precluded. The IVDR carries the same two rules. ([MDR Annex VII s. 1.2.3, 1.2.9][MDR]; [IVDR Annex VII s. 1.2.3, 1.2.9][IVDR])

MDCG guidance draws the line:

| Activity | How the guidance treats it |
|---|---|
| Advice on how to comply, including any involvement in design, risk management or manufacturing processes, except third-party conformity assessment | Consultancy |
| A gap analysis or a mock-up file review before application | Consultancy |
| A check of scope, class, orphan-device status and device codes before a quotation | A legal requirement |
| Structured dialogue: exchanges of technical information and regulatory guidance on what needs to be fulfilled, with questions that are not open-ended | Encouraged before and during assessment; it should not entail extra fees, its cost being integrated into the pre-application and assessment fees |

([MDCG 2019-6 Rev.5, questions I.6.1 to I.6.3][MDCG 2019-6]; [MDCG 2022-14, action 15][MDCG 2022-14])

Our reading, the label for our interpretation where a text leaves room, is that whether a question falls on the permitted side depends on its subject, its context and the stage of the assessment, as well as on its wording. Asking what a requirement means is guidance. Asking the notified body to review a draft clinical evaluation before application asks it to assess.

Implementing Regulation (EU) 2026/977 requires a notified body to have documented procedures so that it gives a quotation only once it holds ten kinds of information. These rules do not apply where the written agreement was signed before 25 February 2027. ([Implementing Regulation 2026/977 Art. 1(1), 8][IR 977])

**Where the option narrows.** A manufacturer may not apply to a second notified body in parallel for the same procedure, and declares any earlier application it withdrew or had refused. Our reading is that the choice of body narrows once the application is lodged. ([MDR Art. 53(1) to (3)][MDR]; [IVDR Art. 49(1) to (3)][IVDR]) Chapter 8 covers the work with the notified body.

## 3. Check 2: Which EUDAMED obligations apply before a module is mandatory?

EUDAMED has seven electronic systems under the MDR: device registration, the Unique Device Identifier (UDI) database, economic operators, notified bodies and certificates, clinical investigations, vigilance and post-market surveillance, and market surveillance. The IVDR names performance studies in place of clinical investigations. ([MDR Art. 33(2)][MDR]; [IVDR Art. 30(2)][IVDR])

A UDI is a series of characters that allows unambiguous identification of specific devices on the market. ([MDR Art. 2(15)][MDR])

A system becomes mandatory once the Commission verifies from independent audit reports that it works and publishes a notice in the Official Journal. Its obligations apply 6 months after the notice. Until then, the provisions of Directives 90/385/EEC and 93/42/EEC, which the MDR repealed, continue to apply regarding information on vigilance reporting, clinical investigations, registration and certificate notifications. The IVDR rule is the same, with Directive 98/79/EC and performance studies. ([MDR Art. 34(2), (3), 123(3)(d)][MDR]; [IVDR Art. 113(3)(f)][IVDR])

The deferral lists provisions article by article, including Articles 70 to 77 on clinical investigations and Articles 87 and 88 on serious incidents and trends. Rules left off the list are not deferred, such as the general requirements in MDR Article 62 and IVDR Articles 57 and 58. ([MDR Art. 62, 123(2), (3)(d)][MDR]; [IVDR Art. 57, 58, 113(2)][IVDR])

MDCG 2021-1 Rev.1 says the Directive provisions continue for the purpose of the exchange of information. Its interim practices do not affect the general obligation to comply with the MDR, including the listed provisions. ([MDCG 2021-1 Rev.1, pp. 3 and 4][MDCG 2021-1])

Our reading follows the guidance, as chapter 11 does: the MDR requirements in the listed provisions apply now, and the Directive provisions continue only for exchanging the information. The guidance is written for the MDR and mentions the IVDR only in connection with a date. For IVDs our reading takes the text as written, so the Directive 98/79/EC provisions continue for the listed information until the module is mandatory. ([MDCG 2021-1 Rev.1, pp. 2 and 3][MDCG 2021-1]; [IVDR Art. 113(3)(f)][IVDR])

Decision (EU) 2025/2371 confirmed as functional the systems for economic operators, UDI and device registration, notified bodies and certificates, and market surveillance. ([Decision 2025/2371 Art. 1, 2][Dec 2371])

The Commission's overview page, read on 29 September 2026, lists six modules, with those four mandatory since 28 May 2026. It gives the clinical investigations and performance studies module as under analysis and vigilance as in development. Both will be released when mandatory, with no voluntary period first. ([EUDAMED overview page][EUDAMED overview]) The current status of each module is published on that Commission page.

**Figure 18.2. Which route carries each EUDAMED exchange of information, as read on 29 September 2026.**

![Figure 18.2: four modules mandatory; for the other two, the route that carries the information and where the MDR requirements stand](figures/figure-18-2-which-rules-carry-each-obligation.svg)



Device registration sits in a mandatory module. The Basic UDI-DI, the basic UDI device identifier, is the primary identifier of a device model. Before placing a device on the market, the manufacturer assigns one, provides it to the UDI database and enters the registration data. ([MDR Art. 29(1), (4); Annex VI Part C s. 1][MDR]; [IVDR Art. 26(1), (3)][IVDR])

Vigilance reporting sits in a module not yet mandatory, and guidance sends serious incidents and field safety corrective actions to the national vigilance systems meanwhile. On the reading set out above, the MDR's reporting requirements already govern those reports. ([MDCG 2021-1 Rev.1, pp. 23 and 24][MDCG 2021-1]) Chapter 11 sets out the interim route.

Legacy devices are those still placed on the market under Article 120(3), (3a) or (3b), such as a device with a valid directive certificate. Devices assessed under Article 52 and legacy devices both get later deadlines if they are placed on the market from 6 months after the notice. Manufacturers have 12 months from the notice for registration data, and notified bodies 18 months for certificates. ([MDR Art. 123(3)(e), (ea)][MDR])

The IVDR sets periods of 6 and 12 months, counted from the date in point (f), for devices assessed under Article 48 or placed under Article 110(3), (3a) or (3b). ([IVDR Art. 113(3)(fa), (fb)][IVDR])

For some devices the Basic UDI-DI precedes the application to a notified body:

| Regulation | Devices |
|---|---|
| MDR, on our reading of Article 29(3) | Class III; class IIb implantable, other than the types Article 52(4) lists; class IIb assessed by type examination |
| IVDR, Article 26(2) | Class D; class C for self-testing or near-patient testing, or assessed by type examination; class B for self-testing or near-patient testing |

([MDR Art. 29(3), 52(3), (4)][MDR]; [IVDR Art. 26(2), 48(3), (4), (7), (8), (9)][IVDR])

**Where the option narrows.** Registration data are due before first placing on the market, with the later periods above where they apply. ([MDR Art. 29(4), 123(3)(e)][MDR]; [IVDR Art. 26(3), 113(3)(fa)][IVDR]) Chapter 9 covers registration, including how point (e) interacts with Article 29(4).

## 4. Check 3: When do the AI Act obligations reach an AI-enabled device?

Under Article 6(1) of Regulation (EU) 2024/1689, the AI Act, an AI system is high-risk when two conditions are met. It is a safety component of a product covered by the legislation in Annex I, or is such a product, and that product needs third-party conformity assessment. Annex I, Section A, lists the MDR at point 11 and the IVDR at point 12. ([AI Act Art. 6(1); Annex I][AI Act])

Our reading is that an AI system that is a device, or a safety component of one, meets both conditions when a notified body takes part in the device's assessment. The dates in the table below are taken from the consolidation of 27 July 2026 and serve as dated examples.

| Provision | Applies from |
|---|---|
| The Act as a whole, with the exceptions in Article 113 | 2 August 2026 |
| Article 50 transparency duties, not among the exceptions | 2 August 2026, on our reading |
| Chapter III Sections 1 to 3, for Annex III systems | 2 December 2027 |
| Chapter III Sections 1 to 3, apart from Article 6(5), for systems high-risk through Annex I | 2 August 2028 |

([AI Act Art. 111(4), 113][AI Act])

Regulation (EU) 2026/1744 set the 2028 and 2027 dates, giving delayed standards, guidance and national authorities as the reasons. ([Regulation 2026/1744 Art. 1, point (40); recital 40][Omnibus]) The application dates in force are in the Official Journal texts, consolidated on the Publications Office site.

Article 50 reaches systems intended to interact directly with people, and systems that generate synthetic audio, image, video or text. ([AI Act Art. 50(1), (2)][AI Act])

The duty to register in the EU database applies to Annex III systems outside point 2, and to systems a provider has concluded are not high-risk under Article 6(3). Our reading is that a device high-risk through Annex I alone falls in neither group. ([AI Act Art. 49(1), (2)][AI Act])

Our reading is that the Chapter III date to which Article 111(2) refers is 2 August 2028 for a system high-risk through Annex I. Recital 39 of Regulation (EU) 2026/1744 calls the rule a grace period whose application depends on when the first unit of a type and model was placed on the market. ([Regulation 2026/1744, recital 39][Omnibus])

Without affecting the Article 5 prohibitions, the Act then applies to a system placed on the market before that date only if its design changes significantly from that date. Providers and deployers of a system intended for use by public authorities have to take the necessary steps to comply by 2 August 2030 in any case. Our reading is that whether the 2030 deadline applies depends on the system's intended use, whoever the early customers turn out to be. ([AI Act Art. 111(2)][AI Act])

On 16 December 2025 the Commission proposed moving the MDR and the IVDR from Section A of Annex I to Section B. The proposal is not law, and the Parliament's procedure page, saved on 29 September 2026, gives its stage as awaiting committee decision. ([COM(2025) 1023 Art. 4][COM 1023]; [Legislative Observatory, 2025/0404(COD)][OEIL])

**Where the option narrows.** Our reading is that a design change after 2 August 2028 to an AI-enabled device already on the market needs an AI Act check before release. Chapter 10 covers the AI Act.

## 5. Check 4: When does a distribution partner take on the manufacturer's obligations?

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

Our reading is that the agreement on which the exception rests is a document that has to exist before the label is printed.

Translating the manufacturer's information and changing outer packaging are not such modifications, if certain conditions are met. The distributor or importer marks the activity and its details on the device or, where impracticable, on the packaging or an accompanying document, under a quality management system. ([MDR Art. 16(2), (3)][MDR])

At least 28 days before making the relabelled or repackaged device available, the distributor or importer informs the manufacturer and the competent authority and submits a notified body certificate for its quality management system. MDCG 2021-26 says simply splitting a shipment into smaller quantities is not repackaging, if the outer packaging is not affected. ([MDR Art. 16(4)][MDR]; [IVDR Art. 16(4)][IVDR]; [MDCG 2021-26, Question 4][MDCG 2021-26])

A distributor verifies the CE marking, declaration, manufacturer's information and, where applicable, UDI before making a device available. It forwards complaints and suspected incidents to the manufacturer, and keeps a register of complaints, non-conforming devices, recalls and withdrawals. Each economic operator has to be able to identify to the competent authority, for the period in Article 10(8), whom it directly supplied and who directly supplied it. ([MDR Art. 14(2), (5), 25(2)][MDR])

The manufacturer's post-market surveillance plan forms part of the technical documentation, and addresses information, including feedback and complaints, from users, distributors and importers. ([MDR Annex III s. 1][MDR]) The manufacturer assigns the UDI, and only the manufacturer may place it on the device. MDCG 2026-5 accepts two UDI-DIs under two brand names, linked only to the manufacturer. ([MDR Annex VI Part C s. 2.2, 2.3][MDR]; [MDCG 2026-5, Background][MDCG 2026-5])

**Where the option narrows.** Our reading is that the agreement that the manufacturer stays on the label and remains responsible has to be in place before the partner first sells under its own name, and relabelling needs 28 days' notice. Chapter 1 sets out who carries which obligation in the channel.

## 6. Check 5: When can early scientific advice still be requested?

For class III devices, and class IIb active devices intended to administer or remove a medicinal product, the manufacturer may consult an expert panel. The consultation covers its clinical development strategy and proposed investigations, and comes before its clinical evaluation or investigation. The manufacturer documents its consideration of the panel's views in the clinical evaluation report, and may not invoke any rights to those views in a later conformity assessment. ([MDR Art. 61(2)][MDR])

The European Medicines Agency (EMA) guide of 17 January 2025, which is guidance, accepts questions on clinical aspects only, and on investigations not yet started. The advice itself will not be published. ([EMA/23357/2025, sections 1.1, 1.3 and 3.2][EMA guide])

HTA is a multidisciplinary process that summarises the medical, patient, social, economic and ethical aspects of using a health technology. A joint clinical assessment is the scientific compilation and description of a comparative analysis of the available clinical evidence against other technologies or existing procedures. ([HTA Regulation Art. 2(5), (6)][HTAR])

A joint scientific consultation is open where a technology is likely to be selected for joint clinical assessment and its clinical studies are still at the planning stage. Its outcome has no legal effect on Member States, the Coordination Group or the developer. For a device, the joint scientific consultation and the expert panel consultation may run in parallel at the developer's request. The Coordination Group sets at least three request periods a year, with dates fixed by 30 November for the following year. ([HTA Regulation Art. 16(1), (2), (5), 17(2)][HTAR]; [Implementing Regulation 2025/117 Art. 2][IR 117])

**Where the option narrows.** Both consultations are available only before the clinical work they would inform has started. Chapter 6 covers clinical and performance evidence.

## 7. Check 6: Can the device reach joint clinical assessment?

The HTA Regulation names two device groups, each only if selected. One is class IIb or III devices for which an expert panel gave a scientific opinion under MDR Article 54. The other is class D IVDs for which the panel gave its views under IVDR Article 48(6). ([HTA Regulation Art. 7(1)(c), (d)][HTAR])

The first gate the device has to pass is the clinical evaluation consultation procedure. Under the MDR it covers class III implantable devices and class IIb active devices intended to administer or remove a medicinal product under Rule 12 of Annex VIII, subject to three exemptions. The panel then decides, on three criteria, whether to give an opinion at all. ([MDR Art. 54(1), (2); Annex VIII s. 6.4; Annex IX s. 5.1][MDR])

Commission guidance to the panels says novelty alone does not trigger an opinion, and an expected major negative clinical impact does. For class D IVDs, the panel gives views where no common specifications exist and it is the first certification for that type. ([Commission guidance 2020/C 259/02, section 2][CECP guidance]; [IVDR Art. 48(6)][IVDR])

The second gate is selection for joint clinical assessment. The Commission adopts an implementing act selecting devices, at least every two years, on criteria that include incorporation of AI software. Under the Coordination Group's guidance, the EMA gives information on every eligible device and IVD, the Group recommends which to select, and the Commission adopts an implementing decision. ([HTA Regulation Art. 7(4)][HTAR]; [Coordination Group selection guidance V2.1, section 1][HTACG selection])

A device considered but not recommended may still be selected later. ([Implementing Regulation 2025/2086, recital 8][IR 2086])

The joint clinical assessment report describes relative effects and their certainty, with no judgement on overall clinical added value. Member States give it due consideration, keep their own conclusions on added value, and may not ask again for evidence submitted at Union level. ([HTA Regulation Art. 9(1), 13(1)][HTAR])

**Where the option narrows.** Once the developer is asked for the dossier, it has 100 days to submit it, extendable in justified cases by at most 30 days. ([Implementing Regulation 2025/2086 Art. 14][IR 2086]) Chapter 12 covers both gates.

## 8. Check 7: What does a German Status 2 decide?

Some new methods cannot yet be paid appropriately with the case flat rates and supplementary fees of the Krankenhausentgeltgesetz (KHEntgG), the German hospital fees act. For those, the contracting parties at hospital level should agree time-limited fees outside the budget. This applies only to methods the Federal Joint Committee (G-BA) has not excluded under § 137c of Book V of the Social Code (SGB V), the provision under which it decides on methods in hospital care. ([KHEntgG § 6(2), sentence 1][KHEntgG]; [SGB V § 137c(3)][SGB V])

Before agreeing such a fee, the hospital has to obtain information from InEK, the Institute for the Hospital Remuneration System, by 31 October at the latest. InEK's page says late requests cannot be considered, refuses requests with incomplete mandatory fields, and can exclude requests with implausible or incomprehensible information. ([KHEntgG § 6(2), sentences 3 and 4][KHEntgG]; [InEK enquiry page, version of 1 September 2026][InEK])

The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) names six statuses for new examination and treatment methods (NUB). Status 1 permits a hospital-specific fee, and under Status 2 agreeing one is not permissible. ([GKV-Spitzenverband NUB page, archived 16 May 2026][GKV NUB]) Our reading is that Status 2 rules out a separate fee for the method covered by that request, and says nothing about whether existing payment covers the device's costs.

**Where the option narrows.** The hospital's request has to reach InEK by the end of 31 October. InEK's dates are on its enquiry page, and chapter 13 covers Germany.

## 9. Check 8: Which specification should an economic model follow?

The General Methods of IQWiG, the German Institute for Quality and Efficiency in Health Care, say health economic evaluations can be run outside § 35b SGB V, which covers the cost-benefit assessment of medicines. For evaluations outside it, the requirements of the reference case essentially apply, depending on the research question, and no universal threshold value is intended. ([IQWiG General Methods 8.0, Section 4.15][IQWiG]; [SGB V § 35b(1)][SGB V])

The reference case is a set of methodological standards that makes evaluations comparable, and the English translation states that only the German text is legally binding. ([IQWiG General Methods 8.0, title page, Section 4.2][IQWiG])

**Where the option narrows.** Our reading is that an economic model built to a named methodological specification can be defended in a second country, and that adopting such a specification costs least before the first national submission. Chapter 14 covers the economic model.

## 10. Check 9: Where is a tender's weighting set?

Contracting authorities are State, regional or local authorities, bodies governed by public law, and their associations. Under Directive 2014/24/EU they award contracts on the basis of the most economically advantageous tender, without prejudice to national rules on price. That tender is identified on the basis of price or cost, and may include the best price-quality ratio. The Directive applies to procurements whose estimated value, net of value added tax (VAT), reaches the thresholds in its Article 4. ([Directive 2014/24 Art. 2(1)(1), 4, 67(1)][PD])

The weighting of each criterion is stated in the procurement documents, except where price alone decides, and may be a range with an appropriate maximum spread. Where weighting is impossible for objective reasons, criteria are listed in decreasing order of importance. ([Directive 2014/24 Art. 67(5)][PD])

In the Directive's sense, a framework agreement is one between contracting authorities and economic operators. It sets the terms, in particular price, of contracts awarded during a given period, for up to four years save in exceptional cases duly justified. Where a framework has several suppliers, contracts are awarded on its terms, by reopening competition, or by a mix of the two, depending on the terms it sets out. Our reading is that losing a tender does not by itself shut a supplier out of that buyer's business for four years, because whether it does depends on who the parties to the framework are and on its terms for reopening competition. ([Directive 2014/24 Art. 33(1), (4)][PD])

**Where the option narrows.** Our reading is that the option narrows at the tender deadline, and that the procurement documents show which national transposing law the tender runs under. Chapter 15 covers procurement.

## 11. Check 10: What does a funding scheme pay for?

As a dated example, the European Innovation Council (EIC) Accelerator page, read on 30 September 2026, describes a grant for innovation activities. It also describes an investment component, offered as direct equity or quasi-equity such as convertible loans. ([EIC Accelerator page][EIC])

The EIC Work Programme 2026 says the grant covers innovation activities, including demonstration, prototyping, research and development (R&D) and testing to meet regulatory and standardisation requirements, intellectual property management and marketing approval. The investment component is intended to finance market deployment and scale up, and can be requested in parallel. ([EIC Work Programme 2026, pp. 75 and 76][EIC WP])

**Where the option narrows.** Our reading is that one scheme can fund two stages of the same entry programme, and that what each scheme pays for is limited by its eligibility text as it stands at the date of application. Current calls are tracked in the funding instrument inventory, and chapter 17 builds the funding plan.

## 12. Check 11: What duties attach to a clinician on an expert panel or in HTA joint work?

Expert panel members act with impartiality and objectivity, neither seek nor take instructions from notified bodies or manufacturers, and may have no industry interests that could affect their impartiality. Their declarations are public. ([MDR Art. 106(3), 107(1)][MDR])

Under Implementing Decision (EU) 2019/1396, each advisor updates the declaration before appointment, before a specific task and whenever circumstances change. Where that is not done, the Commission or Secretariat may take all appropriate measures. The Secretariat, which the EMA provides, publishes the names of appointed and assigned advisors and of those on the central list of available experts. ([Implementing Decision 2019/1396 Art. 12, 14][Dec 1396]; [Regulation 2022/123 Art. 30][Reg 123])

Our reading is that the advisor declares the interest and the Commission or the Secretariat decides what follows, so the company cannot settle by itself how the interest is treated.

In HTA joint work, clinical experts declare their interests and take no part until the Commission has assessed the declaration. Annex II of Implementing Regulation (EU) 2024/2745 limits participation for consultancy, strategic advisory and investigator roles over periods such as the past 3 or 5 years. ([Implementing Regulation 2024/2745 Art. 1(2), 2; Annex II][IR 2745])

An expert in the joint work may intend to work with a developer, and so acquire an interest Annex II treats as incompatible. That expert declares it at once, whether or not a contract is signed. A clinical expert's declaration stays public for one year after the joint work ends. ([Implementing Regulation 2024/2745 Art. 8(4), 11(3)][IR 2745])

**Where the option narrows.** The option narrows before the advisor's next panel task, and when a clinical expert first intends to work with the developer.

## 13. Check 12: Which rules reach investigators and paid clinical relationships?

The sponsor of a clinical investigation takes responsibility for initiating and managing it and for setting up its financing. The investigator conducts it at a site, in a profession the Member State recognises for the role. No undue influence, including financial influence, may be exerted on subjects to take part. ([MDR Art. 2(49), (54), 62(4)(k), 62(6)][MDR])

The IVDR defines the sponsor and investigator of a performance study in the same terms. The undue-influence condition applies to studies within Article 58(1), which include interventional clinical performance studies and studies with surgically invasive sample-taking done only for the study. ([IVDR Art. 2(48), (57), 58(1), (5)(k)][IVDR])

ISO 14155:2026 is the current edition of the International Organization for Standardization (ISO) standard on good clinical practice for device investigations, the 2020 edition having been withdrawn on 23 March 2026. Its catalogue page says it does not apply directly to IVDs, though some requirements may be considered where national or regional rules permit, so on our reading an IVD study plan starts from the IVDR. ([ISO 14155:2026 catalogue page][ISO 14155]; [ISO 14155:2020 catalogue page][ISO 14155:2020])

National transparency registers and pages, read on 30 September 2026, differ:

| Country | What the register or page shows |
|---|---|
| Belgium | A register searchable by professional or by device company |
| Netherlands | Relationships with device companies reported in the past three years |
| Denmark | Rules reaching device companies established in Denmark that manufacture, import or distribute class IIa, IIb or III devices or IVDs |
| Romania | A public sponsorship register for devices |
| France | Reuse of the data restricted to the purpose of transparency |

([beTransparent][BE]; [Transparantieregister Zorg][NL]; [Danish Medicines Agency][DK]; [Romanian device sponsorship register][RO]; [data.gouv.fr, Transparence-santé][FR])

Under the General Data Protection Regulation (GDPR), personal data is any information on an identifiable person, and processing includes collecting and storing it. On our reading, compiling a named list of clinicians is processing. ([GDPR Art. 4(1), (2)][GDPR])

Where the data come from elsewhere, the controller informs each person within a reasonable period and at the latest within one month. Where the data are used for contact, that happens by first contact, and where they are disclosed to another recipient, by first disclosure. The notice names the source, subject to the Article 14(5) exceptions. Each person can object to direct marketing at any time. ([GDPR Art. 14, 21][GDPR])

**Where the option narrows.** Our reading is that settling which transparency and data protection rules apply to a paid clinical relationship costs least before the first payment.

## 14. Check 13: What follows when a tenderer advised the buyer?

Before a procurement, a contracting authority may consult the market and seek advice, if the advice does not distort competition or breach non-discrimination and transparency. Where a tenderer, or an undertaking related to it, advised the authority or helped prepare the procedure, the authority takes measures to keep competition fair. ([Directive 2014/24 Art. 40, 41][PD])

The measures include sharing the relevant information with other bidders and fixing adequate time limits. Exclusion comes only where nothing else ensures equal treatment, after the tenderer has had the opportunity to prove its involvement cannot distort competition. Member States also require authorities to prevent, identify and remedy conflicts of interest. ([Directive 2014/24 Art. 24, 41][PD])

Our reading is that advice from a clinician the company pays, given to a hospital, may count as the company's involvement. The text does not say how an individual's advice is attributed. On that reading, if the company discloses in writing, before the procedure opens, that a clinician it pays has advised the hospital, the authority can take its measures in time.

**Where the option narrows.** Our reading is that the option narrows when the procedure opens.

## 15. How the answer is reached

Each answer takes the previous one as its input:

1. **The commitments**: each dated step in the entry programme model from chapter 17.
2. **The claim behind each one**, with its source: the instrument, article and consolidation date, or the guidance with its revision and date. A claim with no source is a finding in its own right.
3. **The claim's scope**: product and version, class, regulation, Member States and population. A claim true for class III may be false for class IIb, as sections 6 and 7 show.
4. **The thirteen checks**, each against the event in figure 18.1 after which its option narrows.
5. **Each tell against its innocent explanation.** A written record of the innocent explanation answers the question the tell raised. Without one, the tell is a finding, and its remedy has to be in place before the event after which the option narrows.
6. **The volatile facts**, read from their official source on the date relied on. The answers have to be revisited at the events in figure 18.1, at a new consolidation or guidance revision, and at a change of partner, claim or market.

| Check | Where the tell shows, on our observation | Innocent explanation |
|---|---|---|
| 1 | A milestone reading as the notified body's feedback on the approach | A scheduled structured dialogue |
| 2 | A plan row for each EUDAMED module, and none for the obligation each module carries | Duties kept elsewhere, such as the post-market surveillance plan |
| 3 | An AI Act date with no article or check date | A change log holding both |
| 4 | A distribution agreement approved with no regulatory signature | A review held in a separate quality procedure |
| 5 | An expert panel consultation placed after the protocol is locked | A consultation on a previous study |
| 6 | An HTA section naming no MDR or IVDR article | A classification memo settling the first gate |
| 7 | A status letter summarised as a yes or a no, untranslated | A full translation filed with the enquiry |
| 8 | A model specification nobody can name | A technical appendix that names it |
| 9 | A bid weighting with no tender reference | A bid file holding the procurement documents |
| 10 | A scheme name and amount, with nothing on what it funds | An eligibility assessment for each scheme |
| 11 | An advisory board roster never set beside the panel lists | A screening log held by compliance |
| 12 | One name on the investigator and launch engagement lists, with one owner | A documented separation of the roles |
| 13 | A paid clinical relationship and a coming tender at one hospital, undisclosed | A disclosure letter on the tender file |

**Figure 18.3. Where the answer to each check starts: a public document, the company's own files, or a counterparty with its own interests.**

![Figure 18.3: who holds the answer to each check](figures/figure-18-3-who-holds-the-answer.svg)



## 16. The four running cases

The timings, plans, agreements, letters and funding lines below are illustrative assumptions, as are the case facts chapter 1 does not state, such as markets and market status. On our computation, a calculation of ours from the cited dates, the MDR point (e) period ends in late November 2026. That is 12 months after the notice in Decision (EU) 2025/2371, published on 27 November 2025. The IVDR Article 113(3)(fa) period, 6 months from the point (f) date, which is itself 6 months after the notice, ends then too. ([Decision 2025/2371][Dec 2371]; [MDR Art. 123(3)(e)][MDR]; [IVDR Art. 113(3)(f), (fa)][IVDR])

The monitor is assumed to be first placed on the market after that period ends, so MDR Article 29(4) governs its registration. The implant and the test are already on the market. Chapter 9 explains how the months are counted. ([MDR Art. 29(4)][MDR]; [IVDR Art. 26(3)][IVDR])

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

The monitor, already cleared and selling in the United States, is reviewed before the application to a notified body. Chapter 1 classes the hardware IIa under Rule 10, on our reading, and the application separately: IIa if it only records for later review, as planned, and IIb if it analyses the rhythm. Chapter 1 names a sole authorised representative, and Union distributors as importers. The plan lists EUDAMED as a single task scheduled after launch. A Dutch distributor's draft lets it sell under its own brand with no label clause, and the next milestone reads "notified body confirms clinical strategy".

| Question | Answer | Basis |
|---|---|---|
| When are the registration data due? | Before first placing, so a task after launch is too late; each importer verifies the registration and adds its details | [MDR Art. 13(4), 29(1), (4)][MDR] |
| Does the Dutch draft move the manufacturer's obligations? | Yes, as drafted; a clause naming the manufacturer on the label as responsible, agreed before signature, keeps them with the manufacturer | [MDR Art. 16(1)][MDR] |
| Can the body confirm the clinical strategy? | On our reading that asks it to advise; a structured dialogue on what the requirements ask is the permitted form | [MDCG 2019-6 Rev.5, questions I.6.3][MDCG 2019-6] |
| Are early advice and joint clinical assessment open? | No: at class IIa or IIb, a device that administers or removes no medicinal product is outside Article 61(2) and both device groups | [MDR Art. 54(1), 61(2)][MDR]; [HTA Regulation Art. 7(1)][HTAR] |

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

Chapter 1 finds class IIa to III all arguable under Rule 11 and plans the tool as class IIb. It is reviewed three months before first placing on the market in 2027. The plan carries one AI Act date, 2 August 2028, and expects joint clinical assessment because the tool uses AI. An EIC Accelerator grant is to pay the launch sales team. The tool is also offered through an online app platform, as in chapters 9 and 16. The platform offers only third-party apps and lists the tool under the company's name.

| Question | Answer | Basis |
|---|---|---|
| Is it high-risk through Annex I? | Yes, on our reading, because a notified body assesses it | [AI Act Art. 6(1); Annex I][AI Act] |
| Which AI Act dates does the plan need? | Those chapter 10 sets for the tool, which govern; a single date with no article cited is the warning sign check 3 looks for | [AI Act Art. 50, 111, 113][AI Act] |
| Is joint clinical assessment in prospect? | On our reading, no: selection draws only on the two groups, and Article 54(1) does not reach a tool that administers or removes no medicinal product | [HTA Regulation Art. 7(1), (4)][HTAR]; [MDR Art. 54(1)][MDR] |
| Can the grant pay the sales team? | On our reading, no: that is market deployment, which the Work Programme sets against the investment component, offered as direct equity or quasi-equity; which component, if either, covers it is for the scheme to confirm | [EIC Work Programme 2026, pp. 75 and 76][EIC WP]; [EIC Accelerator page][EIC] |
| Is the platform a distributor? | No, on these facts: MDCG 2025-4 treats the upload as placing on the market and a third-party-only platform as an intermediary service, and on our reading Article 16(1) is not engaged while the tool is listed under the company's name | [MDCG 2025-4, pp. 4 and 5][MDCG 2025-4]; [MDR Art. 16(1)][MDR] |

Chapter 10 takes up two open questions: whether a public urgent care centre is a public authority under Article 111(2), and whether a suggestion shown to a triage nurse is direct interaction under Article 50(1).

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

The system is sold in Germany and Italy under its Directive 93/42/EEC certificate and seeks its first MDR certificate. 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. It is reviewed three months before its MDR certificate decision. The plan treats it as placeable until the Article 120(3a) dates, and lists the registration module without the implant's own registration obligation. Its HTA section names no MDR article and has no dossier timetable. A German hospital's enquiry returned Status 2, summarised internally as a yes, and the forecast keeps a separate fee. Two surgeons on the planned advisory board appear on the panel lists.

| Question | Answer | Basis |
|---|---|---|
| May it still be placed on the market? | Only while the certificate is valid under Article 120(2) and the five Article 120(3c) conditions hold, including an MDR quality management system and a formal application to a notified body with a signed written agreement, each by a deadline | [MDR Art. 120(2), (3a), (3c)][MDR] |
| When are its registration data due? | On our reading, within the point (e) period, as a legacy device placed on the market from 6 months after the notice | [MDR Art. 123(3)(e)(ii)][MDR] |
| Can it reach joint clinical assessment? | For the cage, the consultation procedure applies unless an exemption does; only a panel opinion, which the panel may decline within 21 days, and then selection bring it in; a dossier plan prepared in advance, in case the cage is selected, allows the 100-day period to be met | [MDR Art. 54(1), (2); Annex IX s. 5.1][MDR]; [HTA Regulation Art. 7(1), (4)][HTAR]; [Implementing Regulation 2025/2086 Art. 14][IR 2086] |
| Can the forecast keep a German fee? | No: under Status 2 a hospital-specific fee may not be agreed for that request, and a new enquiry reaches InEK by 31 October | [GKV-Spitzenverband NUB page][GKV NUB]; [KHEntgG § 6(2)][KHEntgG]; [InEK enquiry page][InEK] |
| What applies to the two surgeons? | Each updates the declaration before a panel task; on our reading, each role then warrants a written disposition: prohibited for the task, permitted with named safeguards, or unrelated | [Implementing Decision 2019/1396 Art. 12(4), 14][Dec 1396] |

As a dated example, on the consolidation of 19 July 2026 the Article 120(3c) deadlines are 26 May 2024 and 26 September 2024, both passed. The dates in force are in the latest consolidated MDR on the Publications Office site.

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

Chapter 1 plans the test as class C. It is a legacy device, placed on the market under a declaration drawn up under Directive 98/79/EC before 26 May 2022, with no notified body. It is sold through distributors in Germany, the Netherlands, Belgium and Austria, and is reviewed before its performance study protocol is signed. A German distributor acting as importer holds no certificate and intends to relabel boxes and translate the instructions. The plan dates the Basic UDI-DI after the notified body application.

| Question | Answer | Basis |
|---|---|---|
| Can the German distributor relabel? | Translation and repackaging are not modifications, subject to Article 16(2), but it needs 28 days' notice and a quality management system certificate, which it lacks; MDCG 2021-26 says Article 16(2) to (4) do not apply to relabelling on the manufacturer's behalf and under its control, an exclusion Article 16 does not state | [IVDR Art. 16(2), (4)][IVDR]; [MDCG 2021-26, section 2][MDCG 2021-26] |
| When are its registration data due? | On our reading, within the point (fa) period, as a device placed under Article 110(3b) from the point (f) date | [IVDR Art. 110(3b), 113(3)(fa)][IVDR] |
| Which study rules apply now? | Articles 57 and 58; a study within Article 58(1) also meets Articles 59 to 77, and for those deferred, Articles 66 to 73, 74(1) to (13) and 75 to 77, the study information continues to be exchanged under the Directive 98/79/EC provisions until the module is mandatory | [IVDR Art. 57, 58(1), 113(3)(f)][IVDR]; [EUDAMED overview page][EUDAMED overview] |
| When is the Basic UDI-DI due? | Before the application, since a class C test for near-patient testing is on the Article 26(2) list | [IVDR Art. 26(2), 48(7)][IVDR] |
| Does the undue-influence condition apply? | Yes, if the study falls within Article 58(1); whether it does is settled by the protocol, before any site is paid | [IVDR Art. 58(1), (5)(k)][IVDR] |
| Is joint clinical assessment open? | No: only class D IVDs are in the second group | [HTA Regulation Art. 7(1)(d)][HTAR] |

## 17. When specialist help is worth paying for

- **A partner will relabel, repackage or sell under its own name.** ([MDR Art. 16][MDR])
- **The device relies on a directive certificate.** ([MDR Art. 120(2), (3c)][MDR])
- **The device uses AI**, where Article 50, Article 111(2) and the Annex I route each need a reading for the product. ([AI Act Art. 50, 111, 113][AI Act])
- **A paid clinician sits on an expert panel or in HTA joint work.** ([Implementing Decision 2019/1396 Art. 12][Dec 1396]; [Implementing Regulation 2024/2745 Art. 1(2), 2][IR 2745])
- **A paid clinician advises a hospital the company will bid to.** ([Directive 2014/24 Art. 41][PD])
- **Clinicians are paid in a Member State whose transparency rules are unread**, and compiling lists of named clinicians also brings data protection law into play. ([GDPR Art. 4, 14, 21][GDPR])

## Conclusion

The answers to the checks depend on one another through the entry programme, the plan of work, owners, dependencies, and dates that takes a device from development to paid use. Each commitment in the programme rests on a claim about a rule, and the scope of that claim, such as the device's class and countries, decides which checks apply. Each check has an event, shown in figure 18.1, after which the option it protects narrows. A warning sign in the company's own documents, found before that event, raises a question. A written record of an innocent explanation answers it; without one, the warning sign is a finding, and its remedy has to be in place before the event.

For the wearable cardiac monitor from a US company, the registration data are due before first placing on the market, so a database task scheduled after launch comes too late. The Dutch distributor's draft agreement, as written, would move the manufacturer's obligations to the distributor. It lets the distributor sell under its own brand with no clause keeping the manufacturer on the label as responsible. Neither early scientific advice on its clinical studies nor joint clinical assessment, the EU-level comparison of clinical evidence, is open to the monitor, because at class IIa or IIb, and administering no medicinal product, it falls outside both routes.

The triage tool is AI software from a German company. On our reading it is high-risk under the AI Act because a notified body, the organisation that assesses the device, takes part in its assessment. Chapter 10 sets the AI Act dates that govern its plan. On our reading joint clinical assessment is not in prospect, although the plan expects it because the tool uses AI. Its EU innovation grant, on our reading, does not cover the launch sales team, which is market deployment, subject to the scheme's confirmation.

The spinal implant, CE marked under the directive that preceded the MDR, may be placed on the market only while its directive certificate is valid and the transition conditions in Article 120 hold. These include a signed agreement with a notified body by a deadline. Its cage, the class III part, can reach joint clinical assessment only if the expert panel gives an opinion and the cage is then selected. A German hospital's enquiry for the implant returned Status 2, which means a hospital-specific fee may not be agreed for the method covered by that enquiry. The forecast therefore cannot keep one. The near-patient cardiac troponin test comes from a Swiss company. It needs its Basic UDI-DI, the identifier of the device model, before the application to a notified body, whereas the plan dates it after. Its relabelling arrangement cannot depend on a German distributor without the quality management system certificate that relabelling requires. Joint clinical assessment is closed to it at class C, because only class D IVDs, the highest class, fall within the group that can be selected.

## Sources

The last column gives the latest date on which a statement was checked against the version shown.

| Source | Version used | Date of that version | Link | Checked |
|---|---|---|---|---|
| Regulation (EU) 2017/745 on medical devices (MDR), consolidated text | CELEX 02017R0745-20260719, consolidation 007.001 | 19 July 2026 | [Publications Office][MDR] | 30 September 2026 |
| Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), consolidated text | CELEX 02017R0746-20250110, consolidation 005.001 | 10 January 2025 | [Publications Office][IVDR] | 30 September 2026 |
| Regulation (EU) 2021/2282 on health technology assessment | CELEX 32021R2282, as published, OJ L 458 | 22 December 2021 | [Publications Office][HTAR] | 30 September 2026 |
| Implementing Regulation (EU) 2025/2086, joint clinical assessments of devices and IVDs | CELEX 32025R2086, as published | 20 October 2025 | [Publications Office][IR 2086] | 30 September 2026 |
| Implementing Regulation (EU) 2025/117, joint scientific consultations on devices and IVDs | CELEX 32025R0117, as published | 27 January 2025 | [Publications Office][IR 117] | 30 September 2026 |
| Implementing Regulation (EU) 2024/2745, conflicts of interest in HTA joint work | CELEX 32024R2745, as published | 28 October 2024 | [Publications Office][IR 2745] | 30 September 2026 |
| Regulation (EU) 2024/1689 (AI Act), consolidated text | CELEX 02024R1689-20260727, consolidation 001.001 | 27 July 2026 | [Publications Office][AI Act] | 30 September 2026 |
| Regulation (EU) 2026/1744 (Digital Omnibus on AI) | CELEX 32026R1744, Official Journal of 24 July 2026 | 24 July 2026 | [Publications Office][Omnibus] | 30 September 2026 |
| Commission proposal COM(2025) 1023 final, amending the MDR, the IVDR, Regulation (EU) 2022/123 and the AI Act | Proposal, not law | 16 December 2025 | [European Commission][COM 1023] | 30 September 2026 |
| European Parliament Legislative Observatory, procedure 2025/0404(COD) | Page as saved | 29 September 2026 | [European Parliament][OEIL] | 29 September 2026 |
| Commission Decision (EU) 2025/2371, EUDAMED functionality notice | CELEX 32025D2371, as published | 27 November 2025 | [Publications Office][Dec 2371] | 30 September 2026 |
| Implementing Regulation (EU) 2026/977, notified body timelines and quotations | CELEX 32026R0977, as published | 5 May 2026 | [Publications Office][IR 977] | 30 September 2026 |
| Implementing Decision (EU) 2019/1396 on expert panels, consolidated text | CELEX 02019D1396-20250728 | 28 July 2025 | [Publications Office][Dec 1396] | 30 September 2026 |
| Regulation (EU) 2022/123 on the European Medicines Agency, consolidated text | CELEX 02022R0123-20250101, consolidation 001.001 | 1 January 2025 | [Publications Office][Reg 123] | 30 September 2026 |
| Directive 2014/24/EU on public procurement, consolidated text | CELEX 02014L0024-20260101, consolidation 006.001 | 1 January 2026 | [Publications Office][PD] | 30 September 2026 |
| Regulation (EU) 2016/679 (GDPR), consolidated text with the 2018 corrigendum | CELEX 02016R0679-20160504, consolidation 000.002 | 4 May 2016 | [Publications Office][GDPR] | 30 September 2026 |
| MDCG 2019-6, Q&A on requirements for notified bodies | Rev.5 | February 2025 | [European Commission][MDCG 2019-6] | 30 September 2026 |
| MDCG 2022-14, notified body capacity | Original | August 2022 | [European Commission][MDCG 2022-14] | 30 September 2026 |
| MDCG 2021-1, administrative practices until EUDAMED is fully functional | Rev.1 | May 2021 | [European Commission][MDCG 2021-1] | 30 September 2026 |
| MDCG 2021-26, repackaging and relabelling under Article 16 | Original | October 2021 | [European Commission][MDCG 2021-26] | 30 September 2026 |
| MDCG 2026-5, UDI assignment between manufacturers and distributors | Original | July 2026 | [European Commission][MDCG 2026-5] | 30 September 2026 |
| MDCG 2025-4, medical device software apps on online platforms | Original | June 2025 | [European Commission][MDCG 2025-4] | 30 September 2026 |
| Commission guidance to expert panels on the decision criteria in the consultation procedure | 2020/C 259/02 | 7 August 2020 | [Publications Office][CECP guidance] | 30 September 2026 |
| EMA guide to manufacturers on expert panel advice under MDR Article 61(2) | EMA/23357/2025 | 17 January 2025 | [European Medicines Agency][EMA guide] | 30 September 2026 |
| HTA Coordination Group guidance on selecting devices and IVDs for joint clinical assessment | V2.1 | 28 November 2025 | [European Commission][HTACG selection] | 30 September 2026 |
| Commission EUDAMED overview page | Page as read | 29 September 2026 | [European Commission][EUDAMED overview] | 29 September 2026 |
| ISO 14155:2026 catalogue page (status only; the standard is a paid text) | Edition 4 | March 2026 | [ISO][ISO 14155] | 29 September 2026 |
| ISO 14155:2020 catalogue page (withdrawal status only) | Edition 3, withdrawn | 23 March 2026, date of withdrawal | [ISO][ISO 14155:2020] | 29 September 2026 |
| Sozialgesetzbuch Fünftes Buch (SGB V), §§ 35b and 137c | Consolidation, XML build of 10 August 2026 | 10 August 2026 | [gesetze-im-internet.de][SGB V] | 30 September 2026 |
| Krankenhausentgeltgesetz, § 6 | Last changed by the Act of 24 July 2026 | 30 July 2026 | [gesetze-im-internet.de][KHEntgG] | 30 September 2026 |
| InEK enquiry page for new methods | Version of 1 September 2026 | 1 September 2026 | [InEK][InEK] | 30 September 2026 |
| GKV-Spitzenverband overview of new methods | Internet Archive copy | 16 May 2026 | [Internet Archive][GKV NUB] | 30 September 2026 |
| IQWiG General Methods, English translation | Version 8.0 | 19 December 2025 | [IQWiG][IQWiG] | 30 September 2026 |
| beTransparent, Belgian transparency register | Page as read | Not stated | [beTransparent][BE] | 30 September 2026 |
| Transparantieregister Zorg, Netherlands | Pages as read | Not stated | [Transparantieregister Zorg][NL] | 30 September 2026 |
| Danish Medicines Agency, relationships with and financial support from companies | Page as read | Not stated | [Lægemiddelstyrelsen][DK] | 30 September 2026 |
| ANMDMR, device sponsorship register, Romania | Pages as read | Not stated | [ANMDMR][RO] | 30 September 2026 |
| data.gouv.fr, Transparence-santé dataset page | Dataset as listed | Last update 19 May 2026 | [data.gouv.fr][FR] | 30 September 2026 |
| EIC Accelerator page | Page as read | 30 September 2026 | [European Innovation Council][EIC] | 30 September 2026 |
| EIC Work Programme 2026, Annex to Decision C(2026) 4080 | Work Programme 2026 | 17 June 2026, as dated on the EIC Accelerator page | [European Innovation Council][EIC WP] | 30 September 2026 |

[MDR]: http://publications.europa.eu/resource/cellar/e56fc708-95ab-11f1-9262-01aa75ed71a1.0004.03/DOC_1
[IVDR]: http://publications.europa.eu/resource/cellar/bb7d3f94-cd06-11ef-be2a-01aa75ed71a1.0007.03/DOC_1
[HTAR]: http://publications.europa.eu/resource/cellar/177f73e7-62c9-11ec-a033-01aa75ed71a1.0006.01/DOC_1
[IR 2086]: http://publications.europa.eu/resource/cellar/36fefc7c-ad4e-11f0-89c6-01aa75ed71a1.0006.01/DOC_1
[IR 117]: http://publications.europa.eu/resource/cellar/436ec8ac-dc51-11ef-be2a-01aa75ed71a1.0006.01/DOC_1
[IR 2745]: http://publications.europa.eu/resource/cellar/636b794e-94d4-11ef-a130-01aa75ed71a1.0006.01/DOC_1
[AI Act]: http://publications.europa.eu/resource/cellar/b1730fb2-8f1c-11f1-9262-01aa75ed71a1.0001.02/DOC_1
[Omnibus]: http://publications.europa.eu/resource/cellar/b459c07f-86fb-11f1-bf5e-01aa75ed71a1.0006.01/DOC_1
[Dec 2371]: http://publications.europa.eu/resource/cellar/52629153-cb32-11f0-8da2-01aa75ed71a1.0006.01/DOC_1
[IR 977]: http://publications.europa.eu/resource/cellar/ace4a0e9-481a-11f1-8095-01aa75ed71a1.0006.01/DOC_1
[Dec 1396]: http://publications.europa.eu/resource/cellar/daae0744-b440-11f0-b37f-01aa75ed71a1.0006.03/DOC_1
[Reg 123]: http://publications.europa.eu/resource/cellar/2a6dfd43-c1fe-11ef-91ed-01aa75ed71a1.0007.03/DOC_1
[PD]: http://publications.europa.eu/resource/cellar/385cb957-f086-11f0-8d3c-01aa75ed71a1.0007.03/DOC_1
[GDPR]: http://publications.europa.eu/resource/cellar/5f2552c2-cc45-11e6-ad7c-01aa75ed71a1.0022.02/DOC_1
[COM 1023]: https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf
[OEIL]: https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0404(COD)
[MDCG 2019-6]: https://health.ec.europa.eu/document/download/9c9c532f-013a-477c-9378-0a9e714e5549_en?filename=md_mdcg_qa_requirements_notified_bodies_en.pdf
[MDCG 2021-1]: https://health.ec.europa.eu/document/download/ea0369a7-d86c-465e-9a54-0c0dfb01bc84_en?filename=2021-1_guidance-administrative-practices_en.pdf
[MDCG 2025-4]: https://health.ec.europa.eu/document/download/ec9b0f40-7f82-43a7-b833-ebd45b772eae_en?filename=mdcg_2025-4_en.pdf
[MDCG 2022-14]: https://health.ec.europa.eu/document/download/2db053bc-283c-4d2e-93f4-c3e8032e66da_en?filename=mdcg_2022-14_en.pdf
[MDCG 2021-26]: https://health.ec.europa.eu/document/download/4c7bd740-d7c3-4f7b-9a4d-249121a67b8a_en?filename=md_mdcg_2021_26_en.pdf
[MDCG 2026-5]: https://health.ec.europa.eu/document/download/f34c1afd-8d01-44cc-bf94-33e4bcac0ef2_en?filename=mdcg_2026-5_en.pdf
[CECP guidance]: http://publications.europa.eu/resource/cellar/2b51101d-d874-11ea-adf7-01aa75ed71a1.0006.01/DOC_1
[EMA guide]: https://www.ema.europa.eu/en/documents/other/guide-manufacturers-procedure-requesting-advice-expert-panels-clinical-investigations-or-clinical-development-strategies-high-risk-medical-devices_en.pdf
[HTACG selection]: https://health.ec.europa.eu/publications/guidance-htacg-recommendation-selection-medical-devices-and-vitro-diagnostic-medical-devices-jca_en
[EUDAMED overview]: https://health.ec.europa.eu/medical-devices-eudamed/overview_en
[ISO 14155]: https://www.iso.org/standard/83968.html
[ISO 14155:2020]: https://www.iso.org/standard/71690.html
[SGB V]: https://www.gesetze-im-internet.de/sgb_5/
[KHEntgG]: https://www.gesetze-im-internet.de/khentgg/__6.html
[InEK]: https://www.g-drg.de/neue-untersuchungs-und-behandlungsmethoden-nub/drg/anfrageformular
[GKV NUB]: https://web.archive.org/web/20260516175242id_/https://www.gkv-spitzenverband.de/krankenversicherung/krankenhaeuser/drg_system/neue_untersuchungs_und_behandlungsmethoden_nub/neue_untersuchungs_und_behandlungsmethoden_nub.jsp
[IQWiG]: https://www.iqwig.de/methoden/general-methods_version-8-0.pdf
[BE]: https://www.betransparent.be/
[NL]: https://zoeken.transparantieregister.nl/
[DK]: https://laegemiddelstyrelsen.dk/en/licensing/relationships-with-and-financial-support-from-companies/
[RO]: https://sponsorizari-dm.anm.ro/afisare-2022/beneficiari
[FR]: https://www.data.gouv.fr/fr/datasets/transparence-sante-1/
[EIC]: https://eic.ec.europa.eu/eic-funding-opportunities/eic-accelerator_en
[EIC WP]: https://eic.ec.europa.eu/document/download/52598755-1351-4b54-b46b-e2682d0a3aec_en?filename=EIC-Work-Programme-2026.pdf