Article

The era of EU HTA has officially begun—but how will medical devices be affected?

  • Mareike Konstanski

    Mareike Konstanski, MSc

  • Kim Joline Schmidt

    Kim Joline Schmidt, MSc

  • Ruairi ODonnell

    Ruairi O'Donnell, PhD

The Regulation on Health Technology Assessment for the European Union (EU HTAR) has been officially applied since 12 January 2025. With the process for medicinal products now underway, and as we await initial insights from the first joint procedures for medicinal products, let's take a closer look at the details of the procedures for medical devices which will be fully implemented in 2026.

Current status of the EU HTA rollout

As of February 2025, five out of six implementing acts have been adopted, with the act covering JCA for MDs still outstanding (see Table 1). The implementing act on Joint Scientific Consultation (JSC) for MDs is the most recently published act, and it provides crucial insights into the upcoming processes for MD companies, as detailed below.
htaq
The EU HTAR started in January 2025 for medicinal products, specifically for oncology products and advanced therapy medicinal products (ATMPs) with new active substances with a stepwise rollout to all medicinal products and medical devices (MDs) until 2030. According to the HTAR, only specific high-risk MDs and in vitro diagnostic medical devices (IVDs) will qualify for a joint clinical assessment (JCA) starting in 2026. This includes MDs classified as Class IIb and III, for which the relevant expert panels have issued a scientific opinion as part of the already established clinical evaluation consultation procedure, and IVDs classified as Class D, for which the expert panels have provided their assessments.

MDs classified as Class IIb and III

Outlined in Article 51 of Regulation (EU) 2017/745 on Medical Devices (MDR), for example:

  • Blood bags
  • All devices used for contraception or prevention of the transmission of sexually transmitted diseases
  • All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only

IVDs classified as Class D

Specified in Article 47 of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR):

Devices intended to be used for

  • Detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues, or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation, or cell administration
  • Detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation
  • Determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management

Expert panel consultation

For MDs: Defined in Article 54 of the MDR

For IVDs: Defined in Article 48(6) of the IVDR

Table 1. Status of the implementing acts 

Implementing act
Deadline
Status

Procedural rules for JCA of medicinal products

Q1−Q2 2024

Adopted 23 May 2024

Procedural rules on cooperation with the EMA

Q3 2024

Adopted 18 October 2024

Procedural rules for the management of conflict of interest

Q3 2024

Adopted 25 October 2024

Procedural rules for JSC of medicinal products

Q3 2024

Adopted 18 November 2024

Procedural rules for JSC of MDs and IVD MDs

Q1 2025

Adopted 24 January 2025

Procedural rules for JCA of MDs and IVD MDs

Q2 2025

In preparation
Key: EMA – European Medicines Agency; IVD – in vitro diagnostic; JCA – Joint Clinical Assessment; JSC – Joint Scientific Consultation; MD – medical device. 

Insights from the implementing act on JSCs for MDs and IVDs

Parallel consultations

The aim of these consultations is to facilitate the process of preparing JCAs by manufacturers to obtain guidance on the information, data, analyses, and other evidence likely to be required from clinical studies for the JCA.

The implementing act details that companies can request JSCs to take place in parallel with existing consultation with MD expert panels (see Figure 1). In these cases, the HTA secretariat, which facilitates the JSCs, and the EMA, which acts as secretariat for the expert panel, should communicate relevant information to ensure that both consultations are coordinated effectively. To facilitate the preparation of a timely and high-quality briefing package, companies are encouraged to seek assistance from the assessor and co-assessor from the JSC subgroup during this new process, as the process of requesting a parallel consultation on clinical development plans represents a new pathway for MD manufacturers. They should further submit the same documentation to both the HTA secretariat and the expert panel when JSCs occur alongside expert panel consultations to streamline operations and minimise administrative burdens.
htaq graph figure
Figure 1. Key stakeholders and responsibilities in the JSC for MDs

Requesting a consultation

Requests can be submitted during the request period, which is a specific time period to be defined by the 30th of November each year for the following year. There should be three request periods per year for MDs, but only one for MDs and IVD MDs for 2025, which will take place from the 2nd to 30th of June 2025 by the Member State Coordination Group on HTA (HTA CG). The HTA CG plans to initiate one to three JSCs for MDs as part of their annual work program in 2025.

Upon submitting their request for a JSC, companies may also request a meeting with the assessor, co-assessor, other members of the JSC subgroup, and relevant staff from the HTA secretariat to seek assistance relevant to the preparation of the briefing package. The manufacturer will receive a timetable detailing the deadlines for submission of the briefing package from the HTA secretariat. Finally, during the consultation, besides representatives of the manufacturer, the assessor, and co-assessor, as well as other representatives of the JSC subgroup, individual clinical, patient, and other relevant experts (“individual experts”) identified by the HTA secretariat and staff members of the HTA secretariat supporting the JSC subgroups, will participate. For parallel consultations, the advisor of the expert panel consultation and staff members of the EMA supporting the expert panel will participate as well. 
Person reviewing documentation

Outcome document

Before the consultation takes place, an outcome document will be drafted based on the submitted briefing package by the assessor and co-assessor, who may request additional information from the manufacturer through the HTA secretariat. The identified individual experts will have the opportunity to provide input for the draft outcome document. After the receipt of comments by the manufacturer and the consultation meeting, the assessors will prepare the final draft of the outcome document, including specific recommendations to individual Member States. Next, the assessors will submit it to the Coordination Group, who will approve the document before the Commission sends the JSC outcome document to the manufacturer 10 working days after its finalisation, at the latest.

Outstanding documents

Besides the implementing act on the procedural guidance on the JCA for MDs and IVDs, there are some guidance documents specific to MDs that are expected to be published in the first quarter of this year, and which will help companies prepare for JSC (see Table 2).
Table 2. Outstanding guidance documents for medical devices

Document name
Deadline
Status

Procedural guidance for JSC on MDs and IVD MDs

Q1 2025

In preparation

Format and template of requests from health technology developers for JSC – MDs and IVD MDs

Q1 2025

In preparation

Format and template for the dossier submitted by the health technology developer for JSC – MDs and IVD MDs

Q1 2025

In preparation

Format and template for the JSC outcome document MDs and IVD MDs

Q1 2025

In preparation

Guidance for the selection of JSC for MDs and IVD MDs

Q2 2025

In preparation

Procedural guidance on JCA for MDs and IVD MDs

Q3 2025

In preparation

Guidance for the selection of MDs and IVD MDs for JCA

Q3 2025

In preparation

Guidance on filling in the JCA dossier template – MDs and IVD MDs

Q3 2025

In preparation

Guidance on filling in the JCA report template – MDs and IVD MDs

Q3 2025

In preparation
Key: IVD – in vitro diagnostic; JSC – Joint Scientific Consultation; MD – medical device. 

Conclusion

While there are many outstanding important documents affecting MDs and IVDs that companies must prepare for the EU HTA, the implementing act on the JSC already gives a peek into the upcoming processes. There seems to be recognition that current processes for MDs and IVDs are not as aligned as for medicinal products, making this an even more ambitious endeavor for companies. While recognising this, outstanding documents should be published soon to enable companies and other stakeholders to build out internal structures as well as gauge potential impact on the current access pathways before JCA will be applied to their devices from 2026. 

 

Sources

  • European Commission. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 2017. Accessed 10 January 2025. https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng 
  • European Commission. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. 2017. Accessed 10 January 2025. https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng 
  • European Commission. Regulation (EC) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on Health Technology Assessment and Amending Directive 2011/24/EU. 2021. Accessed 10 January 2025. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R2282
  • European Commission. Health technology assessment – joint clinical assessments of medical devices. 2024. Accessed 10 January 2025. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13707-Health-technology-assessment-joint-clinical-assessments-of-medical-devices_en 
  • European Commission. Health technology assessment – joint clinical assessments of medicinal products. 2024. Accessed 10 January 2025. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13708-Health-technology-assessment-joint-clinical-assessments-of-medicinal-products_en
  • European Commission. Health technology assessment – procedural rules for assessing and managing conflicts of interest. 2024. Accessed 23 September 2024. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13751-Health-technology-assessment-procedural-rules-for-assessing-and-managing-conflicts-of-interest_en
  • European Commission. Health technology assessment – cooperation with the European Medicines Agency. 2024. Accessed 10 January 2025. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14164-Health-technology-assessment-cooperation-with-the-European-Medicines-Agency_en
  • European Commission. Health technology assessment – joint scientific consultations on medical devices & in vitro diagnostic medical devices. 2024. Accessed 10 January 2025. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13752-Health-technology-assessment-joint-scientific-consultations-on-medical-devices-in-vitro-diagnostic-medical-devices_en 
  • European Commission. Health technology assessment – joint scientific consultations on medicinal products for human use. 2024. Accessed 10 January 2025. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13759-Health-technology-assessment-Joint-scientific-consultations-on-medicinal-products-for-human-use_en
  • European Commission. Implementation rolling plan. Updated January 2025. Accessed 10 January 2025. https://health.ec.europa.eu/document/download/397b2a2e-1793-48fd-b9f5-7b8f0b05c7dd_en
  • EMA. New EU rules for health technology assessments become effective. 2025. Accessed 28 January 2025. https://www.ema.europa.eu/en/news/new-eu-rules-health-technology-assessments-become-effective
  • Member State Coordination Group on Health Technology Assessment (HTA CG). Annual Work Programme 2025. V1.0. 28 November 2024. Accessed 10 January 2025. https://health.ec.europa.eu/document/download/9f1d2ac8-3515-4be1-9a29-db3d9ffb5201_en?filename=hta_hatcg_awp_en.pdf


This article summarises Cencora’s understanding of the topic based on publicly available information at the time of writing (see listed sources) and the authors’ expertise in this area. Any recommendations provided in the article may not be applicable to all situations and do not constitute legal advice; readers should not rely on the article in making decisions related to the topics discussed.

 

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