# Which economic evidence can be built once, and what does each country set?

## Introduction

A CE marking allows a device to be sold, and each country still decides whether to pay for it and at what price. Several of the bodies behind those decisions ask the company for economic evidence. At its centre is an economic evaluation, which sets the device's added cost against its added health effect compared with the alternatives, and often a forecast of what the device adds to the payer's spending.

For a company planning several countries, the question is which parts of that evidence can be built once and reused, and which each country sets for itself. An economic model is the calculation that combines clinical, cost and other data and projects them forward. The answer decides whether entering a second country means changing the inputs of an existing model or building a new one.

The question arises for medical devices and in vitro diagnostic medical devices (IVDs), including software.

Four illustrative products run through the book. The monitor is a wearable cardiac monitor from a US company, and the triage tool is software enabled by artificial intelligence (AI) from a German company. The implant is a spinal implant system certified under the former Medical Devices Directive, and the near-patient test a cardiac troponin test from a Swiss company. The sources were checked on 30 September 2026.

## In short

Regulation (EU) 2021/2282 on health technology assessment (HTA), the HTA Regulation, leaves pricing and reimbursement decisions to each Member State. It adds a joint clinical assessment, an EU-level review of clinical evidence, and a Member State assessing a technology subject to one may not ask again for evidence already submitted at Union level. ([HTAR Art. 1(2), 13(1)(d)][HTAR])

On our reading, the label for this book's own interpretation, the clinical inputs, the care pathway, the list of resource-use items, and the model structure can be built once and reused. That holds wherever the clinical evidence covers the alternative care the country compares against. Each country sets its own perspective, meaning whose costs and health effects count, and its own discount rates and unit costs. A model that holds those settings as separate inputs can switch countries without being rebuilt. ([IQWiG 8.0, s. 4.9, Table 5][IQWiG]; [PMG36, s. 4.2.7, 4.4.1][PMG36 ch4]; [HAS guide 2020, rec. 19][HAS guide])

In France, a device listed or renewed on the list of reimbursable devices for individual use needs an economic evaluation when two conditions hold. The company claims an improvement of level I, II or III on the French health authority's scale of added benefit, and turnover in the indication, before tax, is €20 million or more a year. A paediatric extension of an indication already covered for adults is excepted. At first listing the turnover that counts is the company's own forecast, so on our reading a device can meet the test before it has made a sale. ([HAS decision 2022.0212, title, arts 1, 4.1, 4.2][HAS decision])

The claimed level is also the principal factor in the French tariff. On our reading, a company that claims a lower level to avoid the evaluation also gives up the principal basis for a higher tariff. ([CSS art. L165-2][CSS L165-2])

In England, the route by which the National Institute for Health and Care Excellence (NICE) evaluates a product decides which of its two methods manuals applies. Each judges the result against its own range of cost per quality-adjusted life year (QALY), a measure combining length and quality of life. A positive technology appraisal requires the relevant health bodies to fund the technology within a set period, while guidance under NICE's HealthTech programme carries no such requirement. ([PMG36, introduction][PMG36 intro]; [PMG36, update information][PMG36 updates])

## 1. Does the HTA Regulation reach economic evidence?

The HTA Regulation defines health technology assessment as a multidisciplinary process that summarises a technology's medical, patient and social aspects and its economic and ethical issues. Its non-clinical domains include the cost and economic evaluation of a technology. ([HTAR Art. 2(5), 2(7); recital 4][HTAR])

The Regulation does not affect a Member State's competence to decide on the use of a technology in its own health context. It does not interfere with national pricing and reimbursement decisions, which it treats as an exclusive national competence. ([HTAR Art. 1(2)][HTAR])

Recital 14 says a joint clinical assessment, the Union-level clinical evaluation, should not predetermine pricing and reimbursement decisions or their criteria. Recital 15 says the Regulation should not restrict a Member State's right to perform non-clinical assessments of the same technology, before, during or after a joint report. ([HTAR recitals 14, 15][HTAR])

A recital sits in the numbered preamble. Our reading is that it explains how the articles are read and does not itself create an obligation.

Under Article 13, a Member State running a national HTA on a technology whose joint clinical assessment has been published or initiated gives due consideration to the joint report. It annexes the report and the developer's dossier to its own documentation. It may not request at national level evidence the developer submitted at Union level under Article 10(1) or (5). ([HTAR Art. 13(1)(a) to (d)][HTAR])

Spain applies the same rule to the national clinical evaluation of a device or IVD with a joint report. Those provisions concern the clinical evaluation report, and do not say the economic evidence is covered. ([RD 415/2026, arts 10(m), 11(e)][RD 415])

Our reading is that the HTA Regulation stops a Member State asking a second time for evidence already filed at Union level, and leaves the economic model to national rules.

## 2. What does an economic evaluation report?

Spain's decree describes the economic evaluation as relating the additional health results a new technology is expected to provide to the additional resources it requires. The German Institute for Quality and Efficiency in Health Care (IQWiG) reports that relation as the incremental cost-effectiveness ratio (ICER). ([RD 415/2026, art. 12(2)][RD 415]; [IQWiG 8.0, s. 4.1][IQWiG])

The National Institute for Health and Care Excellence (NICE) is the English evaluation body. It defines the reported ratio as the expected additional total cost divided by the expected additional quality-adjusted life years, each one a QALY. Both are measured against alternative technologies, called comparators. ([PMG36, s. 4.2.16][PMG36 ch4])

NICE publishes its methods in two manuals: PMG36, for technology appraisal and highly specialised technologies, and PMG48, for its HealthTech programme. IQWiG and NICE each set a reference case, a set of methodological standards that serves the comparability and quality of evaluations. ([PMG36, s. 4.2.1][PMG36 ch4]; [IQWiG 8.0, s. 4.2][IQWiG])

The French national health authority, the Haute Autorité de Santé (HAS), and the Swedish Dental and Pharmaceutical Benefits Agency, Tandvårds- och läkemedelsförmånsverket (TLV), also name analysis types.

| Analysis | What it relates | Named by |
|---|---|---|
| Cost-utility | Cost to health effects in QALYs, which take account of both length and quality of life | IQWiG, both NICE manuals, HAS, TLV |
| Cost-effectiveness | Cost to selected clinical outcomes | IQWiG, HAS |
| Cost-minimisation | Which option has the lowest total cost, where the device has shown at least as much benefit | TLV, as possibly sufficient |
| Cost-comparison | Similar benefits at similar or lower cost than a comparator; in a technology appraisal, one already recommended by NICE for the same population | Both NICE manuals; PMG48 says this can be the case where the only benefit falls to the healthcare system |

([IQWiG 8.0, s. 4.4][IQWiG]; [PMG36, s. 4.2.14, 4.2.18, 4.2.20][PMG36 ch4]; [PMG48, s. 2.1.27, 2.3.2][PMG48]; [HAS guide 2020, rec. 2][HAS guide]; [TLV handbook 1.0, choice of method][TLV handbook])

HAS says the choice between cost-utility and cost-effectiveness analysis depends first on the nature of the health consequences. The quality weights in a QALY are called utilities, and IQWiG's reference case bases them on valuations by patients. ([HAS guide 2020, rec. 2][HAS guide]; [IQWiG 8.0, Table 5][IQWiG])

A budget impact analysis answers a different question. IQWiG describes it as an assessment of the direct financial consequences of reimbursing an intervention, including how a change in the treatment mix may affect future spending. The HAS guide calls economic evaluation and budget impact analysis complementary. ([IQWiG 8.0, s. 4.13][IQWiG]; [HAS guide 2020, foreword][HAS guide])

Uncertainty is the third result an economic submission reports. IQWiG says the forms of uncertainty in a decision analysis need to be addressed, in particular through sensitivity analyses. NICE asks for sensitivity analyses wherever alternative plausible assumptions and inputs exist. ([IQWiG 8.0, s. 4.11][IQWiG]; [PMG36, s. 4.6.1][PMG36 ch4])

In an invented example, as an illustrative assumption, a device costs €2,000 more per patient than its comparator, and avoided admissions save €800 per patient, all in the year of treatment. It adds 0.08 QALYs. Our computation, the label for arithmetic of our own, puts the net cost difference at €2,000 less €800, which is €1,200 per patient. The ratio is €1,200 divided by 0.08, which is €15,000 per QALY.

With 4,000 eligible patients a year, all treated, the added spending on the device is 4,000 times €2,000, which is €8 million a year. Net of the avoided admissions it is 4,000 times €1,200, which is €4.8 million. Our reading is that a payer can accept the cost per QALY and still question the total added spending.

With an effect of 0.04 QALYs, the ratio would be €30,000 per QALY, double the first figure. Our reading is that a ratio is best reported together with whether the cost difference and the health difference are each positive or negative, because a device that costs less and does worse also produces a positive ratio.

## 3. What do the national methods share?

IQWiG, NICE and TLV share two expectations of the model.

| Expectation | IQWiG | NICE | TLV |
|---|---|---|---|
| A decision-analytic model | The standard; it combines effectiveness, cost and other data from several sources, including a study run alongside a trial, and extrapolates beyond the study period | Needed for most evaluations | Often needed to cover the relevant time horizon, and able to adjust trial data to clinical practice or Swedish conditions |
| A model that can be reproduced | Documentation complete enough for full reproduction | Structural assumptions and data inputs fully documented and justified, following accepted guidelines | The model itself in a transparent, adjustable format such as Excel, with a technical description |

([IQWiG 8.0, s. 4.9, Table 5][IQWiG]; [PMG36, s. 4.6.1, 4.6.2][PMG36 ch4]; [TLV handbook 1.0, model analysis, s. 3.1][TLV handbook])

Extrapolation means estimating effects beyond the period the studies observed. IQWiG asks for at least one conservative and one justified optimistic extrapolation scenario. For HealthTech, NICE accepts that models may need strong assumptions, provided they are clearly highlighted and their impact is explored in sensitivity or scenario analyses where possible. ([IQWiG 8.0, Table 5][IQWiG]; [PMG48, s. 2.3.10][PMG48])

The model rests on a care pathway for the indication, which IQWiG names as an important basis for any health economic evaluation. IQWiG also says modelling is unsuitable for demonstrating added benefit under section 35a of the German social code, because a model rests on combined sources and assumptions. ([IQWiG 8.0, s. 4.9][IQWiG])

Our reading is that the clinical evidence of benefit has to exist first, and the model then carries it forward.

For costs, only the identification of resource use can be shared between countries. IQWiG's reference case records direct medical and non-medical costs, reimbursable and not. It says valuing resource use may need a combination of bottom-up, top-down, micro- and macro-costing. ([IQWiG 8.0, Table 5][IQWiG])

The valuation is national. NICE values resources at the prices relevant to the National Health Service (NHS) and personal social services. HAS values them at unit production costs in France, or French tariffs where that is not possible. ([PMG36, s. 4.4.1][PMG36 ch4]; [HAS guide 2020, rec. 19][HAS guide])

For diagnostics, NICE says evaluations may include intermediate outcomes such as test accuracy. A model uses them to predict later health outcomes, and their uncertainty should be quantified and presented. ([PMG36, s. 4.6.12][PMG36 ch4])

As read on 30 September 2026, the sources set the same economic method for a medical device and an IVD. Where they differ, it is on whether a product is assessed at all, under Spain's scope rules and France's list of devices for individual use, and, in NICE's manual, on the outcomes an evaluation of a diagnostic may include.

Our reading is that this shared layer can be reused in a country where the clinical evidence covers the comparator that country uses. The national settings applied to the model, the unit costs and any request for a budget impact analysis are each country's own.

**Figure 14.1. What is built once, and what each country sets.**

![Figure 14.1: the shared layer is built once, and the national settings sit on top of it as inputs that can change](figures/figure-14-1-built-once-set-per-country.svg)



## 4. Which settings does each country fix?

Within a reference case, IQWiG calls the analysis with fixed parameter values the base case, on which the sensitivity analyses build. A discount rate reduces future costs and health effects to their present value. The rates below are as read on 30 September 2026. ([IQWiG 8.0, s. 4.2][IQWiG]; [HAS guide 2020, rec. 7][HAS guide])

| Setting | Germany, IQWiG | England, NICE | France, HAS | Sweden, TLV |
|---|---|---|---|---|
| Perspective | The statutory health insurance community | Health effects for patients and, when relevant, carers; costs to the NHS and personal social services | Collective: everyone affected in health or cost; a health-system perspective has to be argued | Societal: all relevant costs and revenues, whoever bears them |
| Base-case discount rate | 3 per cent a year after the first year | 3.5 per cent a year for costs and health effects | The public rate in force; 2.5 per cent below 30 years when the guide was published in July 2020 | No rate in the handbook read |
| Rates tested | 0 and 5 per cent | Disaggregated results with and without discounting; 1.5 per cent, which the committee may consider where all three criteria in section 4.5.3 are met: otherwise death or a very severely impaired life, likely restoration to full or near-full health, and benefits sustained over a very long period | 4.5 per cent and zero, at least | No rate in the handbook read |

([IQWiG 8.0, s. 4.3.4, 4.8][IQWiG]; [PMG36, s. 4.2.7, 4.5.1 to 4.5.3, 4.10.4][PMG36 ch4]; [HAS guide 2020, rec. 3, rec. 7, s. 1.7][HAS guide]; [TLV handbook 1.0][TLV handbook])

Spain's decree sets the perspective in principle as that of the National Health System, considering other aspects where relevant. Its other settings are left to guidelines not yet published. ([RD 415/2026, art. 12(2)][RD 415])

As read on 30 September 2026, the sources give no threshold value against which to compare a cost per QALY for Germany, France or Sweden. IQWiG does not intend a universal threshold, inside or outside section 35b, and says there is no generally accepted threshold for Germany. ([IQWiG 8.0, s. 1.4, 4.15][IQWiG])

IQWiG asks for a time horizon that fits the indication, the study duration, long-term effects, the cost period, treatment dynamics and the decision-maker's perspective. It adds a 5-year horizon as a sensitivity analysis. HAS applies discounting once the horizon exceeds 12 months. ([IQWiG 8.0, s. 4.3.5][IQWiG]; [HAS guide 2020, rec. 7][HAS guide])

Our reading is that if a setting is built into the model structure, so that it cannot be changed as an input, the model has to be rebuilt for the second country. The current values are in each body's methods document, cited above.

## 5. Which range applies in England?

England lies outside the Union, since under the Withdrawal Agreement Union law ceased to apply to the United Kingdom, subject to the Agreement's own arrangements. The transition period ended on 31 December 2020. ([WA preamble, Art. 126][WA])

The Medicines and Healthcare products Regulatory Agency (MHRA) says the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) do not apply in Great Britain. It sets its own requirements for placing a device on that market, including registration with it. ([MHRA guidance][MHRA])

Our reading is that the HTA Regulation, including Article 13(1)(d), does not bind NICE either. This chapter uses NICE's methods as a point of comparison, and they apply directly to a company that sells in England.

NICE's committee does not use a precise maximum ICER above which a technology is automatically not cost effective, or below which it is. It publishes ranges instead, given below as read on 30 September 2026. They sit in two manuals, and the route by which NICE evaluates the technology decides which manual applies. ([PMG36, s. 6.3.1][PMG36 ch6])

| Question | PMG36, technology appraisal and highly specialised technologies | PMG48, HealthTech programme |
|---|---|---|
| What it covers | Medicines and HealthTech, including devices, diagnostics and digital technologies, evaluated for technology appraisal or highly specialised technologies guidance | Diagnostics, devices, digital technologies and interventional procedures when the guidance is neither of those; guidance started before 14 July 2025 follows the previous version of PMG36 |
| Lower point | Below £25,000 per QALY gained, the decision is normally based on the cost-effectiveness estimate; £100,000 for highly specialised technologies | Below £20,000 per QALY gained, generally considered cost effective |
| Middle band | £25,000 to £35,000: the committee refers explicitly to factors listed in section 6.3.5 | Above £20,000, listed factors are considered, the first being the certainty of the estimates; from £20,000 to £30,000 an increasingly stronger case is needed |
| Upper band | Above £35,000, or £100,000 for highly specialised technologies, an increasingly stronger case is needed | Particularly above £30,000, an increasingly stronger case is needed |
| What a positive result brings | A requirement that relevant health bodies fund the technology within a set period | Guidance without mandated funding |
| Last update | March 2026, recorded as including the change to the cost-effectiveness threshold, with no figures stated | 17 December 2025, with no threshold change recorded |

([PMG36, introduction][PMG36 intro]; [PMG36, update information][PMG36 updates]; [PMG36, s. 5.10.1][PMG36 ch5]; [PMG36, s. 6.3.4, 6.3.7, 6.3.8][PMG36 ch6]; [PMG48, s. 2.4.4][PMG48]; [PMG48, update information][PMG48 updates])

The two manuals' ranges differ by £5,000 at each end, with PMG48's the lower. The sources read do not show whether the March 2026 threshold change in PMG36 also applies to PMG48.

Our reading is that the difference may reflect the different update dates of the two manuals, and need not mean that NICE intends a different range for each route. On that reading, the route and the current HealthTech range are worth confirming with NICE before either enters a business case.

A switching value is the input value that would change the decision at a given threshold. PMG48's example thresholds for one are £20,000 and £30,000. For technologies likely to iterate quickly after guidance, NICE says threshold analyses on performance or impact parameters can help identify a switching value. ([PMG48, s. 2.3.27][PMG48])

**Figure 14.2. Two ranges in two manuals of different dates.**

![Figure 14.2: both English ranges on one scale, labelled by manual and dated](figures/figure-14-2-two-english-ranges.svg)



## 6. Does Germany ask for an economic evaluation of a device?

Section 35b of Book V of the German Social Code (SGB V) is headed "Kosten-Nutzen-Bewertung von Arzneimitteln", the cost-benefit assessment of medicines. Under it, the Federal Joint Committee (G-BA) commissions IQWiG on an application. The assessment compares with other medicines and forms of treatment, weighing the therapeutic added benefit against the costs. The G-BA decides on the basis of IQWiG's assessment and publishes the decision. ([SGB V §35b(1), (3)][SGB V])

For a medicine under section 35b, IQWiG says the G-BA requires the company to submit a complete dossier, and the evaluation includes a budget impact analysis. The reference case assumes a benefit assessment under section 35a already exists and does not call its result into question. ([IQWiG 8.0, s. 4.1, 4.5][IQWiG])

Outside section 35b, the reference case essentially applies, depending on the research question. There, a budget impact analysis is optional, and the results can be interpreted by reference to the sensitivity analyses or to other evaluations of a comparable question. ([IQWiG 8.0, s. 4.15][IQWiG])

As read on 30 September 2026, none of the German sources shows a statutory health economic evaluation for a device. Chapter 13 covers the German routes a device takes to payment. Our reading is that IQWiG's reference case is still a useful specification for a model intended for German payers, and that the question the German payer actually asks should shape the model first.

## 7. When does France ask for an economic evaluation?

The French code makes reimbursement of medical devices for individual use depend on listing, after an HAS commission's opinion, on the list in article L165-1. Under article L165-2, the tariff of a listed product takes account principally of any improvement in the expected or actual service. ([CSS art. L165-1][CSS L165-1]; [CSS art. L165-2][CSS L165-2])

HAS writes the grade as an improvement in expected benefit (amélioration du service attendu, ASA) or in actual medical benefit (amélioration du service médical rendu, ASMR). The HAS Collège decision of 23 June 2022 concerns products that claim an improvement of level I, II or III. ([HAS web article][HAS article]; [HAS decision 2022.0212, title][HAS decision])

| Filing event | Turnover the decision measures, in the indication, before tax | Economic evaluation needed |
|---|---|---|
| First listing | The company's forecast for the second year of marketing | Where the claimed level is I, II or III and the turnover is €20 million or more a year |
| Renewal | Turnover observed over the 12 months before the request | As for first listing |
| Paediatric extension of an indication already covered for adults | Not applicable: article 4.2 removes the evaluation | No, by exception |

([HAS decision 2022.0212, arts 1, 4.1, 4.2][HAS decision])

Article 1 sets out how HAS decides whether a product has a significant impact on health insurance spending, under article R161-71-3, 2°, of the French social security code. HAS weighs the company's claims about the product's effect on how care is organised and practised, and takes the turnover in the indication into account. ([HAS decision 2022.0212, art. 1][HAS decision])

HAS's web article interprets article R161-71-3 as requiring both the claimed improvement level and a significant impact on health insurance spending, and counts an extension of indication as a listing procedure. The decision entered into force on 1 January 2023. ([HAS decision 2022.0212, arts 1, 6][HAS decision]; [HAS web article][HAS article])

The web article words the renewal test as above €20 million, while the decision, the primary text, says €20 million or more for both cases. Our reading is that a device can meet the first-listing test before it has made any sale, because at first listing the test uses the company's forecast turnover.

Our reading is also that the decision's turnover test applies only to a product that goes onto the L165-1 list. Chapter 13 covers how a device or IVD that does not go onto it is paid for in France.

The claimed level is also the principal factor in the tariff. Our reading is that a company claiming a lower level to avoid the evaluation also gives up the principal basis for a higher tariff. The level is a claim the clinical evidence has to support. ([CSS art. L165-2][CSS L165-2])

At filing, the company sends HAS its forecast turnover and population per year over 3 years, or the observed figures on renewal. These have to match what it sends the economic committee for health products, the Comité économique des produits de santé (CEPS). ([HAS decision 2022.0212, art. 2][HAS decision])

The evaluation ends in an economic opinion from HAS's economic and public health evaluation committee, the Commission d'évaluation économique et de santé publique (CEESP). HAS says the opinion goes to the CEPS to help negotiate the price. It comes in parallel with the opinion of the device committee, the Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS). ([HAS web article][HAS article])

## 8. When will Spain ask for an economic evaluation?

Real Decreto 415/2026 includes costs, resource use, efficiency and budget impact among its non-clinical domains. Its economic and budgetary analysis measures the resources needed to adopt a technology against the health results, in contrast with one or more comparators. The non-clinical evaluation includes that analysis, based on the developer's information and other sources where relevant. ([RD 415/2026, arts 2(d), 2(k), 12(1)][RD 415])

The economic evaluation is required, in accordance with the non-normative guidelines, when the technologies evaluated claim additional clinical value over existing alternatives. The HTA offices review the quality of the developer's analyses and may require their correction. The assessment includes a report on the non-clinical aspects, separate from the clinical report, in one document. ([RD 415/2026, arts 7(1), 12(2), 12(4)][RD 415])

| Point of article 6(1) | Products | Condition |
|---|---|---|
| (d) | Devices classified IIb or III under the MDR | Expert panels gave an opinion in the Article 54 clinical evaluation consultation, and the device has been selected under article 6(2) |
| (e) | IVDs classified D under the IVDR | Panels gave views under Article 48(6), and the device has been selected under article 6(2) |
| (f) | Any other device, procedure, digital technology or organisational model | The HTA Council agrees |

([RD 415/2026, art. 6(1)(d) to (f)][RD 415])

Article 6(2) says a device may be assessed as a technology in general, with all available comparators, or as a specific device, where so determined. As read on 30 September 2026, that paragraph sets no selection criteria. ([RD 415/2026, art. 6(2)][RD 415])

Article 6(3) lists the criteria for prioritising devices under points (d) to (f), including unmet medical need, being the first of its class, and the use of AI or machine learning. Our reading is that point (f) can still reach a device that points (d) and (e) do not. ([RD 415/2026, art. 6(3)][RD 415])

The first instructions and guidelines are due one year from entry into force, which is 20 days after publication. The record of the Boletín Oficial del Estado (BOE), the state gazette, shows publication on 29 May 2026 and entry into force on 18 June 2026.

After that deadline, the decree applies progressively, in phases set by a resolution published in the gazette. Until each phase starts, the previous regime continues where it does not conflict. ([RD 415/2026, third additional provision, fourth final provision, second transitional provision, BOE record][RD 415])

Neither the guidelines nor the phasing resolution had been published on 30 September 2026. The resolution, like the normative instructions, is to be published in the BOE. ([RD 415/2026, art. 22(2), second transitional provision][RD 415])

## 9. What do the Netherlands and Sweden assess?

Zorginstituut Nederland (ZIN) says it uses four package criteria: effectiveness, cost-effectiveness, necessity and feasibility. It describes cost-effectiveness as comparing a treatment's effect with its costs. Here the term names a package criterion, which is wider than the analysis type of the same name in section 2. ([ZIN, Pakketbeheer][ZIN package]; [ZIN, Kosteneffectiviteit][ZIN cost])

The institute says it always assesses a small closed part of the basic package before care can enter it. The page names prescription medicines dispensed by pharmacies, some expensive specialist medicines, and physiotherapy and exercise therapy. It does not name devices. These pages are the institute's own account, and are not a legal text. ([ZIN, Wie heeft welke rol][ZIN roles])

TLV has had a mandate since 2012 to make health economic assessments of medical devices, made permanent in 2020. It does not decide whether health care buys the products, and its assessments aim to give the regions the best possible basis for their decisions. ([TLV mandate page][TLV mandate])

The regions' council for medical devices, MTP-rådet, after medicintekniska produkter, holds their mandate to recommend introduction and use. Its judgement weighs TLV's assessment, society's willingness to pay and the severity of the condition, among other things. It can name a device even where TLV has made no assessment. ([TLV handbook 1.0, s. 2.1.4][TLV handbook])

## 10. When is a budget impact analysis asked for?

IQWiG's budget impact analysis estimates the effect on annual expenditure from the payer's perspective over at least 3 years. In principle it compares at least 2 scenarios, one without the new intervention and one with it, and reports total and incremental spending for each year. ([IQWiG 8.0, s. 4.13][IQWiG])

IQWiG says the value of the analysis lies in a robust calculation framework for testing how each input moves the result. A pragmatic approach counts the costs directly related to using the treatment. Under section 35b, the analysis informs the decision on whether cost coverage is reasonable, which also turns on whether the price is appropriate. ([IQWiG 8.0, s. 4.12, 4.13][IQWiG])

NICE asks for evidence-based baseline treatment rates and expected uptake, with the key assumptions highlighted. It asks for net NHS costs broken down by organisation and budget, such as hospital or primary care and staffing or consumables. Its committees may consider budget impact when exploring decision uncertainty. ([PMG36, s. 4.11.3, 4.11.6, 4.11.9][PMG36 ch4])

| Country | Basis for asking, as read on 30 September 2026 |
|---|---|
| Germany | Part of a section 35b evaluation for a medicine; optional outside section 35b |
| England, technology appraisal | A June 2025 update raised the budget impact test from £20 million to £40 million. Section 5.10.4 applies it to medicines whose net budget impact is expected to exceed £40 million a year in any of the first 3 years. Where the test is met, NICE's guidance executive considers applications to vary the funding requirement, normally for up to 3 years (5.10.30) |
| England, HealthTech | Resource impact assessment can be done alongside or after guidance, and the committee may consider it when judging uncertainty about value for money. The methods chapter read has no £ test, and the sources read name none for devices |
| France | Tied to medicines under article 12.d of the 2021 medicines framework agreement, or accord-cadre, between the CEPS and the industry body, Les Entreprises du médicament (LEEM); HAS describes it as optional but encouraged for a device manufacturer |
| Spain | Always for medicines, and where appropriate for other technologies; the text does not say which devices that reaches |
| Sweden | No passage on budget impact in the TLV handbook read |

([IQWiG 8.0, s. 4.15][IQWiG]; [PMG36, update information, June 2025][PMG36 updates]; [PMG36, s. 5.10.4, 5.10.30][PMG36 ch5]; [PMG48, s. 2.3.29, 2.3.30][PMG48]; [HAS web article][HAS article]; [RD 415/2026, art. 12(3)][RD 415])

The French position is HAS's account on its website, and not a legal text. HAS describes the analysis as estimating the short or medium-term financial consequences of introducing a product. Its guide says sustainability is relevant only once the economic interest has been shown. ([HAS web article][HAS article]; [HAS guide 2020, foreword][HAS guide])

**Figure 14.3. When each country asks for an economic evaluation and a budget impact analysis, as read on 30 September 2026.**

![Figure 14.3: what each country asks for, and on what trigger](figures/figure-14-3-what-each-country-asks-for.svg)



## 11. How the answer is reached

The answers depend on one another, in this order:

1. **The decision each country takes** comes first: the body, the route and the methods document with its version. In England the evaluation route decides which manual applies. In Germany section 35b concerns medicines, and the device route is in chapter 13. ([PMG36, introduction][PMG36 intro]; [PMG36, update information][PMG36 updates]; [SGB V §35b(1)][SGB V])
2. **The trigger** follows. In France it depends on listing under article L165-1, then on the claimed level and the turnover at each first listing, extension and renewal. In Spain it depends on the point of article 6(1) that brings the product into scope, on a claim of added clinical value, and on whether the phase of the decree covering the product has started. ([CSS art. L165-1][CSS L165-1]; [HAS decision 2022.0212, title, arts 1, 4.1][HAS decision]; [RD 415/2026, arts 6(1), 12(2), second transitional provision][RD 415])
3. **The care pathway**, with and without the device, shows each service the device changes, directly or upstream and downstream, as NICE asks for HealthTech. Our reading is that its structure can be shared, and checked against each country's practice. ([IQWiG 8.0, s. 4.9][IQWiG]; [PMG48, s. 2.3.12][PMG48])
4. **The shared evidence layer** holds the clinical effect data against each comparator the target countries are likely to name, as NICE's scope defines them for England. It lists the resource-use items once, keeping direct medical and non-medical items separate, and, for an IVD, includes the test accuracy and its link to later outcomes. ([PMG36, s. 4.2.5, 4.6.12][PMG36 ch4]; [IQWiG 8.0, Table 5][IQWiG])
5. **One documented model structure** is built after checking whether an existing model is adequate and relevant. Our reading is that it holds the perspective, unit costs, discount rates, horizon, utility source, cost categories and comparator as separate inputs. It is documented well enough to be reproduced, in an adjustable format. ([PMG48, s. 2.3.8][PMG48]; [IQWiG 8.0, Table 5][IQWiG]; [TLV handbook 1.0, s. 3.1][TLV handbook])
6. **Each country's settings and unit costs** are then applied, with any analysis outside the reference case presented separately and justified. ([PMG36, s. 4.2.1, 4.4.1][PMG36 ch4]; [HAS guide 2020, rec. 19][HAS guide])
7. **The uncertainty** is tested with the sensitivity analyses each country names, among them the discount rates and a conservative and a justified optimistic extrapolation. For software that will change version, the analysis adds switching values for its performance inputs. ([IQWiG 8.0, s. 4.8, Table 5][IQWiG]; [HAS guide 2020, s. 1.7][HAS guide]; [PMG36, s. 4.10.4][PMG36 ch4]; [PMG48, s. 2.3.10, 2.3.27][PMG48])
8. **The budget impact analysis** is a separate model of spending over at least 3 years and 2 scenarios. Uptake rests on evidence, and net costs are split by organisation and budget. French turnover and population forecasts match what goes to the CEPS. ([IQWiG 8.0, s. 4.13][IQWiG]; [PMG36, s. 4.11.3, 4.11.6][PMG36 ch4]; [HAS decision 2022.0212, art. 2][HAS decision])

Our reading is that the model structure is sound if the model can switch from one country's settings to another's without being rebuilt.

## 12. 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 is classified separately, and is planned as class IIa because it only records for later review; an application that analysed the rhythm would be class IIb. The company already sells the monitor in the United States. As an illustrative assumption, it launches in Germany and the Netherlands together, and France follows.

| Question | Answer | Basis |
|---|---|---|
| Germany | Section 35b does not reach the device; chapter 13 covers the German route | [SGB V §35b(1)][SGB V] |
| Netherlands | The pages read list cost-effectiveness among four package criteria, and name medicines and physiotherapy, not devices, in the closed part | [ZIN, Pakketbeheer][ZIN package]; [ZIN, Wie heeft welke rol][ZIN roles] |
| France, first listing | Assumed listed under L165-1, with an assumed €8 million forecast for the second year; below €20 million, so the test is not met, whatever level is claimed | [HAS decision 2022.0212, arts 1, 4.1][HAS decision] |

Our reading is that none of the three countries is shown to require an evaluation at launch. The Dutch pages show how the institute judges care, not that the monitor needs an assessment. The shared evidence layer would serve a later French filing or a payer negotiation in Germany, and building it can wait until one of those is in prospect.

The monitor's care pathway runs from the recording to a clinician's later review, which is the intended purpose set out in chapter 1. The same model structure can take either the German or the French settings. The perspective moves from the statutory insurance community to the French collective one, and the base-case rate from 3 per cent after the first year to the French public rate. ([IQWiG 8.0, s. 4.3.4, 4.8][IQWiG]; [HAS guide 2020, rec. 3, rec. 7][HAS guide])

As an illustrative assumption, a budget impact analysis, optional outside section 35b, is prepared for German statutory health insurance. It uses the section 2 inputs and assumes uptake of 10, 20 and 25 per cent over three years, against a scenario without the device. ([IQWiG 8.0, s. 4.13, 4.15][IQWiG])

Our computation of the incremental spending on the device is €800,000 in year one, €1,600,000 in year two and €2,000,000 in year three, €4,400,000 in all. This base case counts the costs directly related to using the device, which is IQWiG's pragmatic approach. ([IQWiG 8.0, s. 4.13][IQWiG])

IQWiG says a justified expectation of significant differences in disease costs may be considered qualitatively or in further scenario analyses, depending on reliable data. In such a scenario, our computation of spending net of the avoided admissions is €480,000, €960,000 and €1,200,000 in the three years, €2,640,000 in all. ([IQWiG 8.0, s. 4.13][IQWiG])

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

The triage tool is AI-enabled software, planned as class IIb, with classes IIa to III all arguable under Rule 11. Its home Member State is Germany. As an illustrative assumption, it launches there, then in Spain, and England follows, where the tool also needs access to the Great Britain market under the MHRA's rules. ([MHRA guidance][MHRA])

**Spain.** Point (d) of article 6(1) depends on an expert panel opinion in the MDR Article 54 consultation. That consultation applies to class III implantable devices and to class IIb active devices that administer or remove a medicinal product under Rule 12. ([MDR Art. 54(1)][MDR])

Our reading is that point (d) cannot reach the tool at any of those classes, since it is neither implantable nor a Rule 12 device. That leaves point (f), on digital technology, if the HTA Council agrees. The tool meets one article 6(3) criterion, the use of AI. Once the tool is in scope, an economic evaluation will be required if it claims added clinical value. ([RD 415/2026, arts 6(1)(f), 6(3), 12(2)][RD 415])

**England.** As an illustrative assumption, the tool will change version after NICE issues guidance, which is the situation in which NICE says threshold analyses can help identify a switching value. Our reading is that the performance inputs to test are its sensitivity and specificity, and that the model describes the services it changes, directly and downstream. ([PMG48, s. 2.3.12, 2.3.27][PMG48])

As a further illustrative assumption, the case rests on nurse time saved at triage. PMG48 says the scope may specify cost-comparison where the only benefit falls to the healthcare system. Our reading is that a tool claiming only nurse time may fit that case. If the tool also claims a health effect from faster priority, a cost-utility analysis fits, and the type of analysis is settled when NICE scopes the evaluation. ([PMG48, s. 2.1.27, 2.3.2][PMG48]; [PMG36, s. 4.2.14][PMG36 ch4])

Our reading is that time released counts as spending avoided only where spending falls, such as paid hours no longer needed, and is otherwise capacity released.

On the technology appraisal route, staff costs are reported as their own budget category. On the HealthTech route, NICE can carry out a resource impact assessment itself. The assumptions that link a faster priority to a health outcome are highlighted and explored in scenarios. Chapter 10 covers what the AI Act adds. ([PMG36, s. 4.11.6][PMG36 ch4]; [PMG48, s. 2.3.10, 2.3.29][PMG48])

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

The implant is a spinal implant system. Its cage is class III, its screws and plates class IIb, and its hooks class IIb on the reading of the Medical Device Coordination Group (MDCG) in MDCG 2021-24 rev.1. Rods, wires and pins are open, because Rule 8 does not name them.

The European company holds a certificate under Directive 93/42/EEC, the Medical Devices Directive, and seeks its first MDR certificate. It sells in Germany and Italy under the directive certificate, and has not yet entered France. As an illustrative assumption, Spain and England are later markets. The sources read for this chapter cover no Italian body.

**Spain.** Point (d) covers a class IIb or III device where an expert panel issued an opinion in the Article 54 consultation, and where the device has been selected. Of the implant's components, that consultation reaches the cage, as a class III implantable device. ([RD 415/2026, art. 6(1)(d)][RD 415]; [MDR Art. 54(1)][MDR])

Whether an expert panel gave an opinion on the cage is a fact to check in the cage's own conformity assessment record. Article 6(2) names no selection criteria, so whether the implant will be selected remains open. The article 6(3) criteria that could apply are unmet medical need and being the first of its class. Without both an opinion and selection, the implant can come into scope only under point (f), which needs the HTA Council's agreement. ([RD 415/2026, art. 6(1)(f), 6(2), 6(3)][RD 415])

If the implant is in scope and claims added clinical value, an economic evaluation will be required under guidelines still unpublished. If the implant had a joint clinical assessment, the joint report would be the basis of the Spanish clinical evaluation, while the economic evaluation would stay national. ([RD 415/2026, arts 11(e), 12(2)][RD 415]; [HTAR Art. 1(2)][HTAR])

**France.** The first step is the listing application to the HAS, which chapter 13 covers, and at that first listing the turnover test rests on the company's forecast. As an illustration of a later renewal, suppose observed turnover in the 12 months before it is €22 million. That is €20 million or more, so the turnover test is met, and an economic evaluation is required if the renewal file claims level I, II or III. ([CSS art. L165-1][CSS L165-1]; [HAS decision 2022.0212, title, arts 1, 4.1][HAS decision])

**England.** NICE's scope defines the comparators and the technology's expected place in the care pathway, and which NICE route the implant would take is still open. ([PMG36, s. 4.2.5][PMG36 ch4])

Where the model extrapolates beyond the clinical studies, PMG36 finds several scenarios desirable, including one with no further benefit beyond the implant's use. PMG48 points to PMG36 sections 4.5 to 4.7 for modelling. ([PMG36, s. 4.2.24][PMG36 ch4]; [PMG48, s. 2.3.9][PMG48])

**Germany.** Section 35b does not reach the device, so on our reading a model built for Germany is optional until chapter 13's analysis of the German payment routes identifies a body that asks for one.

### 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. It has two intended purposes, serial and single measurement, and is planned as class C for both until a notified body confirms otherwise. It is a legacy device under a declaration of conformity drawn up under Directive 98/79/EC, as chapter 2 sets out. The Swiss company, with no Union entity, sells it through distributors in Germany, the Netherlands, Belgium and Austria.

In Germany section 35b does not reach the test, and the Dutch pages read name no devices in the closed part. The sources read for this chapter cover neither Belgium nor Austria. As an illustrative assumption, the company weighs Spain as its next market. ([SGB V §35b(1)][SGB V]; [ZIN, Wie heeft welke rol][ZIN roles])

**Model.** NICE treats test accuracy as an intermediate outcome that a model uses to predict later health outcomes. Our reading is that the test changes outcomes through what clinicians do with its result. The pathway therefore shows each result's consequence, such as a falsely normal result leading to a missed diagnosis. ([PMG36, s. 4.6.12][PMG36 ch4])

**Costs.** Spain's budget impact analysis follows normative instructions not yet published on 30 September 2026. Our reading is that, until they are, IQWiG's pragmatic approach is a reasonable starting point, counting the costs directly related to using the treatment. For this test those are the cartridges, the analysers and the staff time per test, set against the laboratory tests they replace. ([IQWiG 8.0, s. 4.13][IQWiG])

**Spain.** Point (e) covers class D IVDs with expert panel views, if selected. Our reading is that point (e) does not reach a class C test, which leaves point (f) and the Council's agreement. The article 6(3) criterion that could apply is unmet medical need. Once in scope, an economic evaluation will be required if the test claims added clinical value. ([RD 415/2026, arts 6(1)(e), (f), 6(3), 12(2)][RD 415])

Our reading is that the economic evidence needed does not depend on where the company is based, because the sources read set no condition on its location. Chapter 13 covers who applies in each country.

### The four cases compared

| Question | Monitor, France | Triage tool, England | Implant, France | Near-patient test, Spain |
|---|---|---|---|---|
| Route | HAS, on listing under L165-1 | NICE technology appraisal or HealthTech, set by NICE's routing | HAS, on first listing under L165-1, then renewal | Point (f), if the Council agrees |
| Trigger | €8 million forecast, so not met at first listing | The route decides which manual, and so which range, applies | The forecast at first listing; in the illustrated renewal, €22 million observed, so met if level I to III is claimed | A claim of added clinical value, once its phase applies |
| Budget impact | Optional but encouraged, on HAS's account | Staff costs as their own category, or NICE's own resource impact assessment | Optional but encouraged, on HAS's account | Where appropriate for technologies other than medicines |
| Outcome | No evaluation at first listing | A recommendation with a funding requirement, or guidance without one | A CEESP economic opinion for the price negotiation, if the level is claimed | A non-clinical report beside the clinical one, if in scope |

([HAS decision 2022.0212, arts 1, 4.1][HAS decision]; [PMG36, introduction][PMG36 intro]; [PMG48, s. 2.1.27][PMG48]; [HAS web article][HAS article]; [RD 415/2026, arts 6(1), 7(1), 12(2), 12(3)][RD 415])

## 13. When specialist help is worth paying for

- **The French turnover forecast is near €20 million**, since the listing test rests on that forecast. ([HAS decision 2022.0212, arts 1, 4.1][HAS decision])
- **NICE's route for the product is unclear**, since the two manuals carry different ranges and dates. ([PMG36, introduction][PMG36 intro]; [PMG48, update information][PMG48 updates])
- **The model has to extrapolate far beyond the trial**, which IQWiG and NICE ask to be justified and tested. ([IQWiG 8.0, Table 5][IQWiG]; [PMG36, s. 4.2.24][PMG36 ch4])
- **The product may enter the Spanish system**, whose guidelines were unpublished on 30 September 2026. ([RD 415/2026, arts 6(1), 12(2)][RD 415])
- **A payer asks for a budget impact analysis for a device**, for which no basis was found in England's HealthTech guidance, Spain's "where appropriate" or the Swedish and Dutch pages read. ([PMG48, s. 2.3.29][PMG48]; [RD 415/2026, art. 12(3)][RD 415])

## Conclusion

The EU's health technology assessment (HTA) Regulation leaves pricing and reimbursement with each Member State, so the economic evaluation remains a matter for national rules. In each country, the route a product takes to payment decides whether an economic evaluation is asked for.

In France, it is asked for when a device on the list of reimbursable devices for individual use, under article L165-1, meets two conditions. It claims an improvement of level I, II or III on the French health authority's scale of added benefit, and its turnover in the indication meets the €20 million test. In Spain, Real Decreto 415/2026 asks for one when a product brought into the decree's scope under article 6(1) claims added clinical value, once the phase of the decree covering it has started. In England, the route by which NICE, England's evaluation body, assesses the product decides which of its two manuals, and so which range of cost per quality-adjusted life year, applies.

On our reading, the label for this book's own interpretation, the clinical inputs, care pathway, resource-use items and model structure can serve every country, while each sets its own perspective, discount rates and unit costs. A model that keeps those national settings as separate inputs can move country without being rebuilt.

For the wearable heart monitor from a US company, none of its three planned markets, Germany and the Netherlands first and France later, is shown on our reading to require an economic evaluation at launch. Its assumed French forecast of €8 million is below the €20 million test. On the same reading, building the evidence shared across countries can wait until a French filing or a payer negotiation in Germany is in prospect.

The AI triage software from a German company can come within the scope of the Spanish decree through point (f) of article 6(1), on digital technology, if the decree's HTA Council agrees. In England, cost-comparison, showing similar benefit at similar or lower cost, may fit if it claims only nurse time saved, and cost-utility, setting cost against quality-adjusted life years, if it also claims a health effect. On our reading, nurse time counts as spending avoided only where spending falls, such as paid hours no longer needed.

The spinal implant system from a European company first needs listing under article L165-1 to enter France. In the illustrated later renewal, observed turnover of €22 million meets the turnover test, so an economic evaluation is required if the renewal file claims level I to III. In Spain, the implant comes within point (d) only if an expert panel gave an opinion on its cage, a class III implantable device, in the MDR's Article 54 consultation, and the device is selected. Whether a panel did so is a fact to check in the cage's own conformity assessment record.

The cardiac troponin test from a Swiss company, a class C IVD, falls outside point (e), which covers class D IVDs, so it can come within scope only through point (f), with the Council's agreement. On our reading, where a company is based does not change the economic evidence needed, since the sources read set no condition on location.

Chapter 12 covers the joint clinical assessment, and chapter 13 the national route and payer. Chapters 15, 16 and 17 cover tenders, price and the cost of building the evidence.

## Sources

Each statement was checked against the version shown on the date in the last column. IQWiG publishes its methods in German, and the German text alone is legally binding. Quotations are from the English translation, whose section numbers match the German.

| Source | Version used | Date of that version | Link | Checked |
|---|---|---|---|---|
| Regulation (EU) 2021/2282 on health technology assessment (HTA Regulation), as published | CELEX 32021R2282, OJ L 458, 22.12.2021, p. 1; a 2024 corrigendum corrects the German text of Article 12(1) only | 22 December 2021 | [Publications Office][HTAR] | 30 September 2026 |
| Regulation (EU) 2017/745 on medical devices (MDR), consolidated text, Article 54(1) | CELEX 02017R0745-20260719 | 19 July 2026 | [Publications Office][MDR] | 30 September 2026 |
| Agreement on the withdrawal of the United Kingdom from the European Union and Euratom (Withdrawal Agreement), preamble and Article 126 | CELEX 12020W/TXT, OJ L 29, 31.1.2020, p. 7 | 31 January 2020 | [Publications Office][WA] | 30 September 2026 |
| MHRA, *Regulating medical devices in the UK* (GOV.UK guidance) | Page as read | Last updated 20 February 2026 | [GOV.UK][MHRA] | 30 September 2026 |
| IQWiG, *Allgemeine Methoden* (German original, legally binding) | Version 8.0 | 19 December 2025 | [IQWiG][IQWiG AM] | 30 September 2026 |
| IQWiG, *General Methods* (English translation) | Version 8.0 | Text of 19 December 2025; translation published 1 July 2026 | [IQWiG][IQWiG] | 30 September 2026 |
| Sozialgesetzbuch V (SGB V), §35b | Build of 10 August 2026, last amended by Art. 1 G v. 26.6.2026 I Nr. 195; the Act of 24 July 2026 (BGBl. 2026 I Nr. 228) does not amend §35b | 10 August 2026 | [gesetze-im-internet.de][SGB V] | 30 September 2026 |
| NICE, technology appraisal and highly specialised technologies guidance: the manual (PMG36), chapters 4, 5 and 6, introduction and update information | Web manual | Last updated 31 March 2026 | [Chapter 4][PMG36 ch4]; [chapter 5][PMG36 ch5]; [chapter 6][PMG36 ch6]; [introduction][PMG36 intro]; [update information][PMG36 updates] | 30 September 2026 |
| NICE, HealthTech programme manual (PMG48), chapter 2 and update information | Web manual | Published 14 July 2025, last updated 17 December 2025 | [Chapter 2][PMG48]; [update information][PMG48 updates] | 30 September 2026 |
| HAS Collège, décision n°2022.0212/DC/SED/SEM, significant impact on health insurance spending | As published; in force 1 January 2023 | 23 June 2022 | [HAS][HAS decision] | 30 September 2026 |
| HAS, *Comprendre l'évaluation économique des produits de santé* (web article) | Web article | Published 25 February 2019, updated 16 January 2023 | [HAS][HAS article] | 30 September 2026 |
| HAS, *Choix méthodologiques pour l'évaluation économique à la HAS* (methodological guide) | 2020 edition, still the current edition on the HAS page on 30 September 2026 | July 2020 | [HAS][HAS guide] | 30 September 2026 |
| Code de la sécurité sociale, articles L165-1 and L165-2 | LEGIARTI000046822845 and LEGIARTI000053278939 | Both in force from 31 December 2025 | [L165-1][CSS L165-1]; [L165-2][CSS L165-2] | 30 September 2026 |
| Real Decreto 415/2026, por el que se regula la evaluación de tecnologías sanitarias | BOE-A-2026-11587, as published; no amendment on the consolidated record | 27 May 2026, BOE No. 131 of 29 May 2026 | [BOE][RD 415] | 30 September 2026 |
| Zorginstituut Nederland, *Pakketbeheer* and *Wie heeft welke rol in pakketbeheer* (web pages) | Pages as read | Read 30 September 2026 | [Pakketbeheer][ZIN package]; [roles][ZIN roles] | 30 September 2026 |
| Zorginstituut Nederland, *Kosteneffectiviteit: krijgen we waar voor ons geld?* | Page as read | 27 October 2025 | [Zorginstituut][ZIN cost] | 30 September 2026 |
| TLV, *TLV:s uppdrag inom medicinteknik* (web page) | Page as read | Last updated 29 August 2022 | [TLV][TLV mandate] | 30 September 2026 |
| TLV, *Handbok för hälsoekonomiska bedömningar av medicintekniska produkter* | Version 1.0 | 4 May 2022 | [TLV][TLV handbook] | 30 September 2026 |

[HTAR]: http://publications.europa.eu/resource/cellar/177f73e7-62c9-11ec-a033-01aa75ed71a1.0006.01/DOC_1
[MDR]: http://publications.europa.eu/resource/cellar/e56fc708-95ab-11f1-9262-01aa75ed71a1.0004.03/DOC_1
[WA]: http://publications.europa.eu/resource/cellar/6b06c8b6-43f0-11ea-b81b-01aa75ed71a1.0006.01/DOC_1
[MHRA]: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
[IQWiG AM]: https://www.iqwig.de/methoden/allgemeine-methoden_v8-0.pdf
[IQWiG]: https://www.iqwig.de/methoden/general-methods_version-8-0.pdf
[SGB V]: https://www.gesetze-im-internet.de/sgb_5/
[PMG36 ch4]: https://www.nice.org.uk/process/pmg36/chapter/economic-evaluation-2
[PMG36 ch5]: https://www.nice.org.uk/process/pmg36/chapter/developing-the-guidance-2
[PMG36 ch6]: https://www.nice.org.uk/process/pmg36/chapter/committee-recommendations-2
[PMG36 intro]: https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation
[PMG36 updates]: https://www.nice.org.uk/process/pmg36/chapter/update-information
[PMG48]: https://www.nice.org.uk/process/pmg48/chapter/methods-for-guidance-produced-in-the-nice-healthtech-programme
[PMG48 updates]: https://www.nice.org.uk/process/pmg48/chapter/update-information
[HAS decision]: https://www.has-sante.fr/upload/docs/application/pdf/2022-08/decision_n2022.0212_dc_sed_sem_du_23_juin_2022_du_college_de_la_haute_autorite_de_sante_relative_a_limpact_significatif_sur_.pdf
[HAS article]: https://www.has-sante.fr/jcms/r_1502595/fr/comprendre-l-evaluation-economique-des-produits-de-sante
[HAS guide]: https://www.has-sante.fr/upload/docs/application/pdf/2020-07/guide_methodologique_evaluation_economique_has_2020_vf.pdf
[CSS L165-1]: https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000046822845
[CSS L165-2]: https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000053278939
[RD 415]: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-11587
[ZIN package]: https://www.zorginstituutnederland.nl/pakketbeheer
[ZIN roles]: https://www.zorginstituutnederland.nl/pakketbeheer/wie-heeft-welke-rol-in-pakketbeheer
[ZIN cost]: https://www.zorginstituutnederland.nl/documenten/2025/10/27/kosteneffectiviteit-krijgen-we-waar-voor-ons-geld
[TLV mandate]: https://www.tlv.se/medicinteknikforetag/tlvs-uppdrag-inom-medicinteknik.html
[TLV handbook]: https://www.tlv.se/download/18.1b1136de1a0185d29179492/1787227775668/handbok_for_halsoekonomiska_bedomningar_av_medicintekniska_produkter_1.0%202022.05.04.pdf