Does Union health technology assessment reach the product?

Introduction#

Since 12 January 2025, the European Union (EU) has run joint clinical assessments of some medical devices and in vitro diagnostic medical devices (IVDs, the tests performed on samples taken from the body). A joint clinical assessment compares the clinical evidence on a product with the alternatives once, at Union level, and each Member State must take the resulting report into account in its own assessment, while remaining free to reach its own conclusion. Pricing and reimbursement stay national. Only a narrow group of high-risk products can be assessed, and the Commission chooses which.

For a company whose product is chosen, the assessment adds a piece of work after certification that runs to set deadlines. Its evidence file, the dossier, is due 100 days after the first request is notified, and an incomplete dossier can end the assessment. A developer, meaning the company that brings the product to market, can also ask for a joint scientific consultation, which is advice on how to design its clinical studies. That is open only for a technology likely to be assessed, and only while its clinical studies are still being planned, so the decision falls early.

The chapter follows four illustrative products: a wearable cardiac monitor from a US company, triage software using artificial intelligence (AI) from a European company, a spinal implant certified under the former directive, and a near-patient cardiac troponin test from a Swiss company.

Regulation (EU) 2021/2282 on health technology assessment (HTA), the HTA Regulation, is stated as published, with no amending act. The Medical Device Regulation (MDR) is stated as consolidated on 19 July 2026 and the In Vitro Diagnostic Medical Device Regulation (IVDR) as consolidated on 10 January 2025. All three were checked on 30 September 2026.

1. What does Union HTA do, and what does it leave to Member States?#

Health technology assessment is a multidisciplinary process. It summarises information about the medical, patient and social aspects of using a health technology, and the economic and ethical issues. The HTA Regulation, cited here as HTAR, applies from 12 January 2025. (HTAR Art. 2(5), 36)

The Regulation sets up cooperation between Member States on health technologies at Union level, and common rules for joint clinical assessment (JCA). It also sets up a mechanism under which the developer submits the evidence for that assessment once, at Union level. (HTAR Art. 1(1))

It takes its definitions of a medical device and of an IVD from the MDR, Regulation (EU) 2017/745, and the IVDR, Regulation (EU) 2017/746. It says its joint work on devices should be separate from the regulatory assessments under those two regulations. (HTAR Art. 2(2), (3); recital 38)

Three Union processes can reach a device or an IVD:

(HTAR Art. 2(6), 2(8), 7(4), 16(1), (2), 17(1), 23(1)(b))

The JCA report describes relative effects on health outcomes and how certain those effects are. It contains no value judgement and no conclusion on overall clinical added value. National pricing and reimbursement decisions stay with the Member States. (HTAR Art. 1(2), 9(1))

Who runs it, and what its guidance is worth#

The Regulation establishes the Member State Coordination Group on Health Technology Assessment (HTACG), which it calls the Coordination Group. Its members are designated by the Member States, and the Commission is its secretariat. It adopts methodological and procedural guidance, and an annual work programme. (HTAR Art. 3(1), (2), (6), 3(7), 6(1))

The Commission adopts implementing acts on procedure. Implementing Regulation (EU) 2025/2086 (IR 2025/2086) lays down the procedure for JCAs of devices and IVDs, and Implementing Regulation (EU) 2025/117 (IR 2025/117) does the same for JSCs. These implementing regulations are law, as the HTA Regulation is. Recitals are the numbered preamble that opens a regulation, and state what it intends. (HTAR Art. 15(1); IR 2025/2086 Art. 1; IR 2025/117 Art. 1)

The Coordination Group's JCA selection guidance and its JCA and JSC procedural guidance each say they are not legally binding. Each also says it does not state the Commission's position. The Commission's frequently asked questions (FAQ) on publication of reports say they set out preliminary views of Commission services, and are not an official position. (JCA selection guidance, cover; JCA procedural guidance, cover; JSC procedural guidance, cover; FAQ on publication, introduction)

Guidance therefore shows how the Coordination Group or the Commission interprets the legal text. "Our reading" marks an interpretation of ours. Our reading is that a plan which relies on an interpretation given in guidance should also check that interpretation against the wording of the rule itself.

2. Which devices can reach a joint clinical assessment?#

The MDR divides devices into classes I, IIa, IIb and III by intended purpose and inherent risks. A medical device is subject to JCA under Article 7(1)(c) of the HTA Regulation when three conditions are met. It is class IIb or III under MDR Article 51. The relevant expert panels have given a scientific opinion in the clinical evaluation consultation procedure under MDR Article 54. The Commission selects it under Article 7(4). (MDR Art. 51(1); HTAR Art. 7(1)(c))

Our reading is that the second condition, the expert panel opinion, decides most cases. MDR Article 54(1) applies the consultation procedure to two groups. One is class III implantable devices, and the other class IIb active devices intended to administer or remove a medicinal product under Rule 12. (MDR Art. 54(1))

An implantable device is one intended to be totally introduced into the body by clinical intervention and to remain after the procedure. So is a device intended to replace an epithelial surface or the surface of the eye. A device partially introduced and intended to remain for at least 30 days is also implantable. (MDR Art. 2(5))

Rule 12 puts active devices that administer or remove medicinal products, body liquids or other substances in class IIa. They move to class IIb where this is done in a potentially hazardous manner, taking account of the substance, the part of the body and the mode of application. A Rule 12 device that stays in class IIa is outside Article 54(1)(b). (MDR Annex VIII, Rule 12; Art. 54(1))

When does the consultation procedure not run?#

A notified body is a conformity assessment body designated under the MDR. A common specification is a set of technical or clinical requirements, other than a standard, that provides a means of complying with legal obligations. Article 54(2) lifts the procedure in three cases:

(MDR Art. 2(42), 2(71), 54(2))

How does the expert panel decide whether to give an opinion?#

Where the procedure runs, the notified body prepares a clinical evaluation assessment report. It sends the report and the manufacturer's clinical evaluation documentation to the Commission, which passes them to the relevant expert panel. Expert panels are those the Commission provides for under MDR Article 106(1), to assess clinical evaluation in relevant medical fields. The same procedure applies where the device is certified by type examination under Annex X. (MDR Annex IX s. 5.1(a), (b); Annex X s. 6; Art. 106(1))

The panel decides whether to give a scientific opinion on three criteria. The first is novelty of the device or procedure and its possible major clinical or health impact. The second and third are a significantly adverse change in the benefit-risk profile, and a significantly increased rate of serious incidents, each in respect of a category or group of devices. (MDR Annex IX s. 5.1(c))

On the same criteria, the panel may decide not to give an opinion. It then tells the notified body within 21 days, with reasons, and the notified body may proceed with certification. Where no opinion arrives within 60 days, the notified body may also proceed. (MDR Annex IX s. 5.1(d) to (f))

Commission guidance for the panels says novelty typically means a lack of experience with the device, its features or the related clinical procedure. Novelty alone is insufficient, and the panel considers the possible major impacts that follow from it. (Expert panel guidance, s. 2)

The guidance says an opinion is required where a major negative impact is anticipated, whatever the degree of novelty. It is typically not required where novelty is not high and no major negative impact is expected. (Expert panel guidance, s. 2.1)

Our reading is that a manufacturer can argue novelty and impact in its file, but cannot see the category-level signals the panel weighs. Whether an opinion will come is therefore unknown until the panel decides.

Which devices does that leave with a route?#

(HTAR Art. 7(1)(c); MDR Art. 2(5), 54(1); Annex IX s. 5.1(d))

3. Which IVDs can reach a joint clinical assessment?#

The IVDR divides IVDs into classes A, B, C and D. An IVD is subject to JCA under Article 7(1)(d) when it is class D under IVDR Article 47 and the relevant expert panels have provided their views under IVDR Article 48(6). Selection by the Commission is the third condition. (IVDR Art. 47(1); HTAR Art. 7(1)(d))

Rule 1 puts in class D tests that screen blood, cells, tissues or organs for transmissible agents before transfusion or transplantation. It also covers tests for transmissible agents causing a life-threatening disease with a high or suspected high risk of propagation. Tests of the infectious load of a life-threatening disease are also class D where monitoring is critical. Rule 2 puts in class D tests for certain named blood group markers. (IVDR Annex VIII, Rules 1, 2)

The expert panel consultation reaches fewer devices than class D does. The notified body consults the experts where no common specifications exist for class D devices, and where it is also the first certification for that type of device. (IVDR Art. 48(6))

Implementing Regulation (EU) 2022/1107 (IR 2022/1107) lays down common specifications for certain class D IVDs, applying from 25 July 2024. They cover blood group antigens in the ABO, Rhesus, Kell, Duffy and Kidd systems, and markers of infections such as human immunodeficiency virus (HIV), hepatitis B, C and D, and cytomegalovirus. (IR 2022/1107 Art. 1, 4)

Our reading is that a class D device of one of those types has common specifications available, so the Article 48(6) condition is not met for it. A class D device of another type is not excluded by that regulation, and the notified body confirms whether the condition is met.

An EU reference laboratory is one the Commission may designate for specific devices or categories, with tasks that include, where appropriate, verifying the performance claimed for class D devices. Where the consultation applies, the notified body sends the manufacturer's performance evaluation report to the expert panel within five days of receiving it. The experts give their views within the deadline for the EU reference laboratory's scientific opinion. (IVDR Art. 48(6), 100(1), (2)(a))

The views go into the notified body's documentation, and the notified body gives them due consideration. (IVDR Annex IX s. 4.9)

A companion diagnostic is a test essential for the safe and effective use of a particular medicinal product. It is class C under Rule 3(f). The Commission's FAQ on scope concludes that companion diagnostics are therefore out of scope of the HTA Regulation. Our reading is that the FAQ means JCA under Article 7(1)(d), since collaborative assessment of IVDs remains open under Article 23. (IVDR Art. 2(7); Annex VIII, Rule 3; FAQ on scope, question 15)

Both routes, the device gate and the IVD gate, end in an expert panel output: an opinion for a device and views for an IVD. A product without that output stays outside the pool of products from which the Coordination Group recommends and the Commission selects.

4. How is a product selected from the pool?#

Eligibility is not selection. After 12 January 2025 the Commission adopts, at least every two years, an implementing decision selecting devices and IVDs for JCA. It first seeks a recommendation from the Coordination Group. (HTAR Art. 7(4))

Under Implementing Regulation (EU) 2024/2699 (IR 2024/2699), the European Medicines Agency (EMA) supplies the information that makes up the pool. From 1 January 2024, no later than 15 days after the end of each quarter, it tells the HTA secretariat of every device with an MDR Article 54 opinion given or intended, and every IVD with views provided or requested. (IR 2024/2699 Art. 3)

For a device, EMA's notification names the manufacturer and notified body, the panel's decision on whether to give an opinion, and the opinion where available. The secretariat passes this to the Coordination Group or its subgroups to prepare the recommendation. (IR 2024/2699 Art. 3(1), 4(2))

The selection guidance says all devices and IVDs with an opinion or views are eligible, and that at least one criterion must be fulfilled to justify selecting one. (JCA selection guidance, s. 2.2, 3.2)

Selection rests on one or more of six criteria in Article 7(4), and the guidance sets out how it reads each of them for devices and IVDs:

(HTAR Art. 7(4); JCA selection guidance, s. 3.2(a) to (f))

What happens after a recommendation?#

After the Coordination Group adopts a recommendation, the HTA secretariat tells each developer with an opinion or views in the period covered whether its device was recommended. It gives reasons where it was, and also informs the expert panel, through EMA. (IR 2025/2086 Art. 2(1), 5)

A recommended developer is invited to send the certificate of conformity and the instructions for use within 7 days of the later of certification and the request. The subgroup may also invite it to give other information needed for the assessment scope, in a meeting or in writing. (IR 2025/2086 Art. 3(1), (2))

For devices the Coordination Group recommends, the notified body tells the HTA secretariat whether it granted or refused the certificate, or whether the developer withdrew its application. It has 7 days from the event, or from the secretariat's information where the event came first. That duty does not apply where the information is already fully available in the European database on medical devices. (IR 2025/2086 Art. 4(2), (3))

The Commission may also select a device the Coordination Group did not recommend. Its developer then has 7 days from the later of certification and the secretariat's request to provide the same information. The procedural guidance says the Commission can do so in specific warranted instances, in accordance with the opinion of the HTA Committee. That committee, set up under Article 33, is made up of Member State representatives and is separate from the Coordination Group. (IR 2025/2086 Art. 2(2); JCA procedural guidance, s. 1; HTAR Art. 33(1); Regulation 182/2011 Art. 5(1))

The Commission adopts the selection decision if that committee gives a positive opinion. After a negative opinion or none, it does not adopt the draft. The chair may then put an amended version to the same committee or the draft to an appeal committee, where a negative opinion also blocks adoption. (HTAR Art. 7(5), 33; Regulation 182/2011 Art. 5, 6)

What had the Coordination Group recommended by 16 September 2026?#

The 2026 work programme said the Coordination Group may start approximately 5 device assessments, the first expected in June 2026. On 22 June 2026 it adopted its first recommendation, for two implantable devices in the circulatory system area. According to the minutes, it drew on every device and IVD with an opinion or views from 1 January 2024 to 31 March 2026. It prioritised on the selection criteria and on how many assessments could start in parallel. (Work programme 2026, s. 2; HTACG 20th meeting flash report and minutes, point 2)

On 16 September 2026 it adopted a second, for two devices. The final selection will be made public once the Commission decision is adopted and the devices are certified. (HTACG 23rd meeting flash report, point 1)

Assuming that the second two devices differ from the first two, which the flash reports do not say, our computation gives 2 + 2 = 4 devices recommended, against about 5 assessments planned. The count covers recommendations only, and says nothing about the probability that a given device will be selected.

Later recommendations appear in the Coordination Group's flash reports on the Commission's HTA pages.

5. What happens once a device is selected, and how long does it take?#

Once the subgroup has appointed an assessor and a co-assessor, from different Member States, the HTA secretariat tells the developer without delay that scoping has started. The assessment scope sets the patient population, the intervention, the comparators and the health outcomes, and Member States request it jointly. (IR 2025/2086 Art. 7; HTAR Art. 2(9), 8(4))

The assessor drafts a scope proposal from the developer's information, consults any JSC outcome document, and has access to the expert panel opinion or views. The Commission's first request to the developer then sets out the finalised scope, the deadline and the dossier template. (IR 2025/2086 Art. 11(1), 12(3); HTAR Art. 10(1))

The periods that follow are set in law:

(IR 2025/2086 Art. 12(2), 13, 14(2), (4), (5), 15, 17(2), (5); HTAR Art. 10(5), 12(3))

According to the procedural guidance, the explanation meeting explains the scope, is not intended to change it, and gives no advice on the data to submit. (JCA procedural guidance, s. 2.3.4)

The Coordination Group endeavours to reach consensus. Where it cannot, divergent opinions go into the reports and the reports are deemed endorsed. The information technology (IT) platform is a public webpage and secure exchanges that the Commission sets up for the Coordination Group, developers and experts. The Commission publishes compliant reports on that platform's public webpage, and the data transparency principles say the dossier is published with them. (HTAR Art. 12(2), (4), 30(1); Transparency principles, publication)

The following computation of ours gives a planning scenario, and the actual duration can be longer. From receipt of the certificate and instructions for use, 60 days for the scope, 100 for the dossier, 165 for the reports and 30 for endorsement make 355 days. Taking the 15 working days of confirmation as 21 calendar days, on an assumed five-day week, gives 355 + 21 = 376 days.

The scenario leaves out two things: the rule that moves the scope deadline to 10 days after the selection decision where that date is later, and any gap between the finalised scope and the first request. It also leaves out the explanation meeting, the extension, further requests, the procedural review and publication. Adding the full 30-day extension gives 376 + 30 = 406 days, a further computation of ours on the same basis.

Our reading is that the period the developer most needs to watch is the 100 days for the dossier, because it opens when the first request is notified. Articles 12(2) and (3) and 14(2) set no period between a finalised scope and that notification, so the law does not fix when the 100 days start.

6. What does the dossier contain, and what happens if it is incomplete?#

The dossier has to be complete for the available studies and data, analysed with appropriate methods, well structured and transparent, and supported by its underlying documentation. For a device it contains the thirteen items of Annex II, point 1. (HTAR Art. 9(2) to (4); Annex II, point 1)

Three items come from certification: the clinical evaluation assessment report, the manufacturer's clinical evaluation documentation, and the expert panel's scientific opinion. Other items include HTA reports on the device where appropriate, registry data, and the characterisation of the condition and of the device, including its instructions for use. (HTAR Annex II, point 1)

Point 1(d) sets out the study evidence required. For studies with the device that the developer sponsored, it requires all up-to-date published and unpublished information, study reports, protocols and analysis plans. For ongoing or discontinued studies, it requires all available information where the developer is a sponsor or otherwise financially involved. It also requires corresponding information on third-party studies, if available. Point 1(d) asks for this information in relation to the assessment scope. (HTAR Annex II, point 1(d))

For an IVD the dossier holds the performance evaluation report and documentation, the expert panel output, and the report of the EU reference laboratory. The HTA Regulation calls that laboratory the Union reference laboratory. (HTAR Annex II, point 2)

The dossier follows international standards of evidence-based medicine, and the developer justifies any departure from the Coordination Group's methodological guidance. The Coordination Group has published guidance on filling in the dossier templates for devices and for IVDs. (IR 2025/2086 Annexes I, II; JCA dossier guidance for devices; for IVDs)

If the dossier still does not meet the requirements after the second request, or arrives late, the Coordination Group discontinues the assessment. The public webpage then carries the Commission's statement, including a list of what the developer did not submit. Article 13(1)(d), which stops Member States requesting nationally the evidence submitted at Union level, then no longer applies. (HTAR Art. 10(6), 13(1), 30(3)(o))

The assessment can restart if a Member State passes on the requested evidence. The Member State shares it within five months of the first submission deadline, and the Commission checks it within 10 working days. The Coordination Group may then re-initiate the assessment within six months of that deadline. (IR 2025/2086 Art. 18(1), (2); HTAR Art. 10(7))

While the assessment reports are being drafted, the developer tells the Coordination Group of new clinical data. New data sent on its own initiative must be considered if it arrives no later than 60 days after the Commission confirms the dossier. (HTAR Art. 11(2); IR 2025/2086 Art. 16(5))

The developer then has 7 days to flag technical or factual inaccuracies in the revised drafts, and information it considers confidential. It does not comment on the results, and the guidance says comments outside a factual accuracy check are not considered. (IR 2025/2086 Art. 16(4); HTAR Art. 11(5); JCA procedural guidance, s. 2.5.2)

7. What does the report settle, and what stays national?#

A Member State assessing the device nationally gives the report due consideration. It annexes the developer's dossier and the published report to its national documentation. It does not request nationally the evidence submitted at Union level, and shares through the IT platform any such evidence it receives. (HTAR Art. 13(1))

Due consideration leaves the Member State free to draw its own conclusion on overall clinical added value. Recital 31 says the report is scientific in nature and should not be binding on Member States, and that a missing report should not delay a national process. (HTAR Art. 13(1); recital 31)

The developer does not submit at national level anything already submitted at Union level. Recital 34 gives the purpose: Member States can then request nationally only evidence not already available at Union level. (HTAR Art. 10(3); recital 34)

Recital 15 says Member States should be able to perform complementary clinical analyses, for example on other patient groups, comparators or outcomes. They should also be able to ask the developer for the evidence needed. It says the Regulation should not restrict their right to perform non-clinical assessments, which cover cost and economic evaluation and ethical, organisational, social and legal aspects. (HTAR recital 15; Art. 2(7))

Member States tell the Coordination Group within 30 days of a national assessment how they considered the report, and the Commission reports on uptake each year. (HTAR Art. 13(2); IR 2025/2086 Art. 19(1))

Our reading is that the report limits what the developer can argue nationally more than it limits the national decision. Each national file annexes the report, with its comparators and outcomes, so a national case built on a different comparator will be read alongside the report.

8. When is a joint scientific consultation open?#

A JSC covers study design, including comparators, interventions, health outcomes and patient populations, and ends in an outcome document with a scientific recommendation. (HTAR Art. 16(1))

A technology is eligible if it is likely to be the subject of JCA under Article 7(1), and its clinical studies or investigations are still in the planning stage. For devices, those studies include the clinical investigations for clinical evaluation, and for IVDs the performance studies for performance evaluation. (HTAR Art. 16(2); recital 39)

The selection guidance reads planning stage as follows. The clinical investigation after feasibility or proof of concept studies, or the IVD performance study, has not started. Its protocol has not been submitted to any regulatory authority. On that reading, a designed protocol that has not been submitted can still qualify, and submission of that investigation's protocol closes the window. Our reading is that a feasibility study still under way does not close it, since the guidance tests the investigation that follows it. (JSC selection guidance, s. 2.2)

The same guidance lists as eligible class III implantable devices, class IIb active devices that administer or remove a medicinal product, and class D IVDs. It notes that notified bodies and panels apply further MDR and IVDR criteria. For an IVD, it applies the test in Article 7(1)(d), which needs the expert panels' views under Article 48(6). (JSC selection guidance, s. 2.1, 2.3)

How is a consultation requested and selected?#

The Coordination Group sets, by 30 November, at least three request periods a year for devices and IVDs, and the planned number of consultations in each. The developer submits its request in a period, through the IT platform. (IR 2025/117 Art. 2, 3)

Where eligible requests exceed the planned number, the Coordination Group selects on six criteria. Five are the same as the Article 7(4) criteria for selecting devices for JCA, leaving out the software criterion, and the sixth is Union clinical research priorities. Within 15 working days of the period closing, the developer learns whether the Coordination Group will engage, with reasons for any refusal. (HTAR Art. 17(3), (4), 7(4))

The selection guidance asks the developer to address each criterion in its request, with an overview of its development plan. (JSC selection guidance, s. 3.2)

Can it run alongside an expert panel consultation?#

A device developer may ask for the JSC to run in parallel with an expert panel consultation under MDR Article 61(2). That provision lets the manufacturer of a class III device, or of a class IIb device under Article 54(1)(b), consult a panel on its clinical development strategy before the investigation. The request template says the parallel route is not available for IVDs. (HTAR Art. 16(5), 17(2); MDR Art. 61(2); JSC request template, first page)

In a parallel consultation the timetables are synchronised, and the meeting is virtual and co-chaired. The developer may ask for its notified body to attend as an observer. (IR 2025/117 Art. 5(2), 13)

What does the outcome document bind?#

The outcome document has no legal effects on Member States, the Coordination Group or the developer. A later dossier explains any deviation from the recommended evidence, and the assessor consults the outcome document when drafting the scope. (HTAR Art. 16(3); Annex II, point 1(g); IR 2025/2086 Art. 11(1))

The assessor and co-assessor of a later JCA must be different from those who prepared the outcome document. Exceptionally, where the necessary expertise is otherwise unavailable, the Coordination Group may approve a justified reappointment. (HTAR Art. 8(4), (5))

What does a consultation cost, and when can it be requested?#

The procedural guidance says the Coordination Group consultation carries no fee, and that EMA may levy fees for this type of consultation. The Commission's 2028 review is to consider whether developers should help finance consultations through fees. As at the check date, the 2026 work programme planned 2 to 5 device consultations over four request periods. (Work programme 2026, s. 1, 4; JSC procedural guidance, s. 7.1; HTAR Art. 31(1))

Current request periods are listed on the Commission's joint scientific consultations page. (Commission JSC page)

9. What reaches a product outside both gates?#

The Commission supports Member State cooperation on collaborative assessments of devices and IVDs. Each year's work programme carries the planned number of assessments under voluntary cooperation. The 2026 programme expects no such assessment to start in 2026, while a working group explores how the cooperation could run. (HTAR Art. 6(2), 23(1)(b); Work programme 2026, s. 5)

Recital 18 says Member States should be able to cooperate voluntarily on class IIb or III devices and class D IVDs that are software and fall outside JCA. Our reading is that "which are software" qualifies both groups. (HTAR recital 18)

A device outside the two gates is outside JCA, and in law remains within reach of collaborative assessment under Article 23(1)(b). Our reading is that, while none is expected to start, this is a dormant route, and the work programme adopted each November shows whether any collaborative assessment is planned. (HTAR Art. 23(1)(b))

10. What would the Commission's proposal change?#

Proposal COM(2025) 1023, of 16 December 2025, would amend the MDR and the IVDR. It would replace MDR Article 54, applying the consultation procedure to class III implantable devices other than custom-made devices. The Commission would gain a power to add other device types by its own act, where justified to protect health and safety. (COM(2025) 1023, title page; Art. 1, point (46))

The proposal would also widen two of the Article 54(2) exemptions. The modification exemption would cover a device already marketed for the same intended purpose, without the words "by the same manufacturer". The common specification exemption would also accept a harmonised standard that addresses clinical evaluation. (COM(2025) 1023, Art. 1, point (46))

It would delete paragraphs 5 and 6 of IVDR Article 48, and paragraph 6 is the consultation whose views Article 7(1)(d) names. The Parliament's procedure file shows the proposal awaiting committee decision. (COM(2025) 1023, Art. 2, point (29); Legislative Observatory, 2025/0404(COD))

11. How the answer is reached#

Each answer takes the previous one as its input:

1. The class and intended purpose come from chapter 1 on classification, since the HTA Regulation uses the MDR and IVDR definitions. (HTAR Art. 2(2), (3))
2. The gate, the condition that can lead to an expert panel output, is the Article 54(1) consultation procedure for a device, and class D with the Article 48(6) consultation for an IVD. A product outside its gate goes to step 7, and an IVD whose notified body has not yet confirmed that Article 48(6) applies is still checked for consultation eligibility at step 6. (MDR Art. 54(1); IVDR Art. 48(6); JSC selection guidance, s. 2.3)
3. The exemptions for renewal, modification or a common specification, as the notified body confirms them, decide whether the consultation procedure runs. Where one applies, no opinion arises and step 7 follows. (MDR Art. 54(2))
4. The panel outcome follows the notified body's report: an opinion, a decision not to give one within 21 days, or no opinion within 60 days. An opinion, or views for an IVD, puts the product in the pool, which EMA reports quarterly. (MDR Annex IX s. 5.1; HTAR Art. 7(1)(c), (d); IR 2024/2699 Art. 3)
5. A developer whose product is in the pool may have to prepare a dossier, and on our reading should plan for that work from the day the opinion is given. A recommendation starts 7-day periods for the developer and the notified body to supply information, and selection requires the point 1(d) study evidence within the 100-day dossier period. (IR 2025/2086 Art. 3(2), 4(2), 14(2); HTAR Annex II, point 1)
6. Consultation eligibility needs a product likely to be assessed and a study still being planned. On the guidance's reading, submission of the investigation's protocol closes the window, and on our reading feasibility studies under way do not close it. A device can ask for the parallel panel consultation at the same time. (HTAR Art. 16(2), 17(2); JSC selection guidance, s. 2.2)
7. Outside both gates there is no JCA route, and voluntary cooperation is a dormant route while the work programme plans none. The evidence plan is then built for national assessments. (HTAR Art. 6(1), 23(1)(b); recital 18; Work programme 2026, s. 5)
8. The pending proposal would change both gates and the exemptions, and each recommendation and selection decision appears in the Coordination Group's meeting reports. (COM(2025) 1023, Art. 1(46), 2(29); HTACG 23rd meeting flash report)

12. The four running cases#

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

Chapter 1, on classification, places the monitor's hardware in class IIa under Rule 10, on its reading. It classifies the companion application separately. The application is class IIa if it only records for later review, which is the planning assumption. It is class IIb if it analyses the rhythm to guide a physician's diagnosis.

Class IIa is outside Article 7(1)(c), which needs class IIb or III. At either class the monitor is outside both groups of devices covered by Article 54(1), since neither part is implantable or administers a medicinal product. No panel opinion arises, so the monitor has no JCA route. (HTAR Art. 7(1)(c); MDR Art. 2(5), 54(1))

Our reading is that a product with no route to assessment is not likely to be assessed, so it is not eligible for a JSC.

Collaborative assessment remains possible in law. Recital 18 names class IIb or III software, so the application at class IIa falls outside that recital. An algorithm that analysed the rhythm would move it to class IIb, still with no JCA route. On our reading, it would then be software of the kind recital 18 names. With no collaborative assessment expected to start in 2026, the monitor's evidence is planned country by country. (HTAR Art. 23(1)(b); recital 18; Work programme 2026, s. 5)

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

Chapter 1 finds classes IIa to III all arguable for the triage tool under Rule 11, and plans it as class IIb. Class IIb satisfies the first condition of Article 7(1)(c). It is not implantable, and it does not administer or remove a medicinal product, so neither limb of Article 54(1) reaches it. Without a panel opinion it cannot meet the second condition. (HTAR Art. 7(1)(c); MDR Art. 54(1))

Chapter 1 gives class III if the tool's decisions may cause death or irreversible deterioration. Our reading is that class III software is still not implantable, so the answer stays the same.

Article 7(4) lists software using AI, machine learning or algorithms as a selection criterion. Our reading is that the criterion applies to such software where it is part of a device that is inside Article 54(1) and can receive a panel opinion, such as an implant or a Rule 12 device. Software that drives a device takes that device's class. On our reading, software driving a class IIb Rule 12 device may therefore fall within Article 54(1)(b), if the notified body accepts the argument. (HTAR Art. 7(4); MDR Annex VIII s. 3.3; Art. 54(1))

Recital 18 contemplates voluntary cooperation on class IIb or III software outside JCA, which on our reading of the recital describes this tool. That route is dormant while the work programme plans none. (HTAR recital 18; Work programme 2026, s. 5)

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

The expert panel guidance says an opinion is typically not required where novelty is not high and no major negative impact is expected. Our reading is that a cage with established predecessors may well receive no opinion, and would then stay outside the pool. (MDR Annex IX s. 5.1; Expert panel guidance, s. 2.1)

Suppose, as an illustrative assumption, that the panel gives an opinion. The device then enters the pool, and the Commission may select it whether or not the Coordination Group recommends it. (IR 2024/2699 Art. 3; IR 2025/2086 Art. 2(1), (2))

If the device is selected, the planning scenario runs 376 days from the certificate and instructions for use to endorsement, with the omissions listed in section 5. At Union level no payer or buyer is named, because pricing and reimbursement stay national, and the output is a report annexed to national HTAs.

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

Chapter 1, on classification, places serial measurement in class C under Rule 3(j), and plans both intended purposes as class C. Article 7(1)(d) needs class D. Our reading is that a cardiac troponin test matches none of the Rule 1 purposes or Rule 2 markers, which set class D. The test has no JCA route, and the single-measurement purpose, class B on the guidance's contested reading, would have none either. (IVDR Annex VIII, Rules 1 to 3; HTAR Art. 7(1)(d))

The JSC eligibility summary lists class D IVDs and no other IVD class, and the parallel panel route is not available for IVDs. Collaborative assessment covers IVDs, and is dormant with none expected to start in 2026. (JSC selection guidance, s. 2.1; JSC request template, first page; HTAR Art. 23(1)(b); Work programme 2026, s. 5)

13. When specialist help is worth paying for#

• The device is inside Article 54(1) and a new investigation is being planned. On the guidance's reading, the decision whether to request a consultation has to be taken before the protocol is submitted, and a later dossier explains deviations from the outcome document's recommended evidence. (HTAR Annex II, point 1(g); JSC selection guidance, s. 2.2)
• The panel has given an opinion. Assembling the point 1(d) study evidence calls for HTA dossier methods, because an incomplete dossier can end the assessment. (HTAR Art. 10(6); Annex II, point 1)
• The device is recommended or selected. The 7-day and 100-day periods run on notifications the company does not schedule. (IR 2025/2086 Art. 3(2), 14(2))
• Information needs to stay confidential. Redaction requests need a justification of commercial sensitivity, and a refusal can be appealed. (IR 2025/2086 Art. 16(4), 21)

Conclusion#

Whether a product can face a joint clinical assessment, the Union-level comparison of its clinical evidence with the alternatives, is settled by a chain of steps, each depending on the one before. The product's class and intended purpose decide whether an EU expert panel can review it during certification. For a device the panel's output is a scientific opinion under the MDR clinical evaluation consultation procedure, and for an in vitro diagnostic (IVD) it is the panels' views. The panel then decides whether to give that output, and only products that receive it can be selected by the Commission.

Once the Commission selects a product, Member State assessors set the scope of the assessment, the company has 100 days from notification of the first request to submit its evidence dossier, and the assessment report follows. A joint scientific consultation, in which the Member States advise on study design, is open only to a technology likely to be assessed whose study is still being planned.

A product that cannot receive a panel output has no route to joint assessment. That covers any device outside the groups the consultation procedure reaches under MDR Article 54(1), implantable class III devices and class IIb active devices that administer or remove a medicine, and any IVD other than a class D test for which the notified body must seek panel views under IVDR Article 48(6). Voluntary cooperation among Member States on a collaborative assessment remains a dormant route while none is planned, so the evidence for such a product is planned for national assessments.

The wearable cardiac monitor from a US company has no route to joint assessment whether its companion application is class IIa or IIb, and on our reading is not eligible for a joint scientific consultation. Its clinical evidence is planned country by country. The AI triage software from a European company, planned as class IIb, is outside both groups of devices covered by Article 54(1), so it has no route either, and on our reading class III would not change that. On our reading, the voluntary cooperation that recital 18 of the HTA Regulation contemplates for class IIb or III software outside joint assessment describes the tool, and that route is dormant while none is planned.

The spinal implant certified under the former directive is the case that may face an assessment. Its interbody cage is class III and implantable, so it is inside Article 54(1)(a) and its certification goes through the consultation procedure. No renewal exemption applies, and on chapter 1's reading no modification exemption applies either. On our reading, a cage with established predecessors may well receive no opinion, which would keep it out of assessment. With an opinion it could be selected, and if it were, our planning scenario puts its assessment at 376 days from receipt of the certificate and instructions for use to endorsement, a figure that leaves out several steps and can run longer.

The near-patient cardiac troponin test from a Swiss company, planned as class C, has no route to joint assessment, because only class D IVDs qualify, and its single-measurement purpose would have none at class B. Its evidence is therefore built for national assessments.

Chapter 6 covers clinical evidence and expert panel advice, and chapter 8 the notified body relationship. Chapter 10 covers what the AI Act adds for software such as the triage tool. Chapter 13 covers the national route, and chapter 14 reusable economic evidence.