From 23 September to 21 October 2026, it is possible to submit requests for Joint Scientific Consultation under the European Health Technology Assessment system. The request period also concerns medical devices and in vitro diagnostic medical devices, according to the conditions set out in the HTA framework.
At a glance
- The request period: requests can be submitted from 23 September to 21 October 2026.
- Technologies concerned: this includes class IIb or III medical devices and class D in vitro diagnostic medical devices that may be subject to a subsequent Joint Clinical Assessment, according to the applicable conditions.
- The purpose: JSCs allow an early scientific exchange on the evidence needed for a subsequent joint clinical assessment. They do not constitute approval of the technology.
What Joint Scientific Consultations are
Regulation (EU) 2021/2282 on Health Technology Assessment introduced a European framework for Joint Scientific Consultations, or JSCs.
These consultations allow health technology developers to discuss information needs and clinical evidence relevant to a subsequent Joint Clinical Assessment, or JCA, during the study planning phase.
The distinction therefore also concerns the timing of the exchange: the JSC concerns the planning of evidence; the JCA provides for the subsequent joint clinical assessment of that evidence.
A consultation does not anticipate the outcome of the assessment and does not amount to recognition of the clinical value of the technology.
Which devices are concerned
The fourth 2026 request period concerns both medicinal products and medical devices. For the latter, the announcement by the European Commission and HaDEA refers to:
- class IIb or III medical devices;
- class D in vitro diagnostic medical devices.
However, the reference to the risk class does not imply automatic access to the consultation. Requests concern technologies that may be subject to JCA under Article 7(1) of the HTA Regulation and are subject to the applicable selection conditions and procedures.
The Commission provides specific guidance for the selection of medical devices and IVDs intended for JSCs.
Why this topic sits alongside MDR and IVDR
HTA and medical device regulation address different aspects of health technologies.
The MDR and IVDR regulate the requirements applicable to devices, including safety, performance, clinical evaluation or performance evaluation, conformity and post-market surveillance.
HTA, instead, considers evidence relating to health technologies in support of decisions by healthcare systems. In this framework, JSCs concern evidence needs for a subsequent joint clinical assessment.
JSCs do not replace the pathways provided for by the MDR and IVDR and do not modify their requirements. They do not represent a new conformity assessment step or an authorisation to place a device on the market.
Their relevance lies in the early exchange on evidence: data collected for regulatory purposes and information needed for an HTA assessment do not necessarily answer the same questions.
Requests, documents and parallel consultations
Requests are submitted through the HTA IT platform, using the documentation indicated by the European Commission.
It is useful to distinguish between two types of documents:
- The request template, used to submit the consultation request.
- The briefing documents, intended to collect the information and questions to be addressed during the scientific exchange.
The official page includes briefing document templates dedicated to medical devices and IVDs, as well as a template for parallel consultations between the Member State Coordination Group on HTA, HTACG, and the Expert Panels for medical devices.
For this request period, HaDEA indicates 21 October 2026 as the deadline for uploading requests and notes that access to the platform may take a few days.
The opening of the request period therefore represents an opportunity for scientific exchange within the European HTA framework. For the medical device and IVD sector, the topic concerns the preparation of evidence for a possible joint clinical assessment, while maintaining the distinction from regulatory pathways.
Official sources
- European Commission — Joint Scientific Consultations
- HaDEA — Health Technology Assessment: new opportunity to apply for Joint Scientific Consultations, 22 settembre 2026
- European Commission — Guidance for the selection of medical devices and IVDs for JSCs
- Regulation (EU) 2021/2282 on Health Technology Assessment
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Informational note
This article is provided for informational purposes only and does not constitute regulatory, legal, technical or professional advice. The applicable requirements and procedures are those set out in the official texts and updated documentation of the competent authorities.