The JSC request window is now open – and it can provide benefits to manufacturers operating in the EU.

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) is transforming market access across Europe. From 2 June through to 30 June, health technology developers (HTDs) of medical devices can for the first time request a Joint Scientific Consultation (JSC), an optional scientific advice service offered to support evidence generation activities in anticipation of undergoing a future Joint Clinical Assessment (JCA). Is it worth considering? In this piece, we lay out the context of this now-open application period and the potential advantages of undergoing a JSC for medical device HTDs. In particular, we explain how JSC can provide key early insights into a product’s evidence needs for JCA to optimize evidence generation strategy.

What is JSC, and why is it important for developers of medical devices and in vitro diagnostic devices?

The JSC is a new and optional scientific advice service described in the Regulation (EU) 2021/2282 on health technology assessment (HTAR).¹ The aims of the JSC are entirely related to the central component of the new EU HTAR, the Joint Clinical Assessment (JCA) – an appraisal of the clinical effectiveness of a new technology in all relevant populations across EU Member States. Given the substantial data requirements of the JCA, the JSC is intended to support health technology developers (HTDs) to optimize their evidence generation activities in order to meet the JCA evidence demands, prior to the initiation of a future assessment.

According to the regulation, only select Class IIb or III medical devices, as well as Class D in vitro diagnostic medical devices, will be chosen for JCA from 12 January 2025 and every 2 years thereafter.¹ The selection criteria of medical devices are the same for JSC and JCA:^1,2

• Unmet medical needs
• First in class
• Significant cross-border dimension
• Potential impact on patients, public health, or healthcare systems
• Incorporation of software using artificial intelligence, machine learning technologies, or algorithms
• Major EU-wide added value

There is currently no additional published guidance on potential weighting of these criteria, or further granularity on criteria definitions. 

As laid out in the Implementation Act for JSC (Regulation [EU] 2025/117), the Coordination Group shall set the dates of JSC request periods, as well as the planned number of JSCs for each of these request periods, by 30 November each year for the subsequent year.² For 2025, the only request period for medical devices is from  2 June to 30 June, 2025, and the available consultation slots are the following:

• 29 September to 2 October, 2025 (Briefing document by 1 September, 2025)
• 27 October to 30 October, 2025 (Briefing document by 29 September, 2025)
• 24 November to 27 November, 2025 (Briefing document by 27 October, 2025)

From our knowledge of JCA, the evidence required of HTDs of medical devices is likely to be increasingly stringent. We also expect that the volume of evidence required will be greater for the EU HTAR compared to the conformity assessment, as clinical evidence needs to be submitted as part of the evidence package for the EU HTAR. Such evidence demands consequently present a new challenge, requiring HTDs to engage early and align with evolving JCA and HTA requirements. JSC offers the paramount opportunity to accomplish this.

Early engagement – fab or fad?

HTDs for medical devices are likely familiar with early engagement. Manufacturers may consult an expert panel to review “the manufacturer’s intended clinical development strategy and proposals for clinical validation” under the 2017 medical devices Regulation (Regulation [EU] 2017/745; Art. 61), prior to the device’s clinical evaluation by the Medical Device Coordination Group (MDCG).³ In addition, avenues for early dialogue with competent authorities or HTA bodies already exist at the national level.

Despite this, a recent survey revealed that general uptake for early dialogue has been low.⁴ While all parties recognized the value of early dialogue, factors such as lack of legal mandate, limited capacity from all parties, and lack of uniform national or international HTA methods for medical devices were cited as reasons for the low level of adoption of early engagement with HTA bodies and competent authorities.

As stipulated in the EU HTAR (Regulation [EU] 2021/2282), the outcomes of the JSC – while non-binding – will be duly considered during the eventual JCA.¹ Additionally, we expect greater capacity with conducting meaningful early dialogues, as promised in this legislation. This inevitably increases the legitimacy of any early engagement going forward. While HTDs can decide to not follow JSC recommendations during the JCA, clear discussion and rationale needs to be provided.

Seizing the opportunity – consideration factors for medical device HTDs

With all this considered, why should HTDs ride the wave and participate in the first JSCs?

1) Streamlined and harmonized evidence generation activities

For medical devices, HTDs can opt for the JSC to be carried out in parallel with the expert panel consultation under the existing medical device regulation.^1,2 This is the equivalent of seeking parallel JSC and EMA scientific advice for medicinal products.

“Consulting an expert panel prior to the clinical evaluation of the medical device under the medical devices Regulation (Regulation [EU] 2017/745) allows the expert panel to review “the manufacturer’s intended clinical development strategy and proposals for clinical investigation”.³ The JSC, meanwhile, is designed to “exchange information with health technology developers on their development plans for a given health technology” – and, in doing so, facilitate the generation of evidence that meets the likely evidence requirements of a subsequent JCA on that health technology.“

The aims of the JSC and the expert panel consultation are, in our view, highly complementary. Consulting an expert panel prior to the clinical evaluation of the medical device under the medical devices Regulation (Regulation [EU] 2017/745) allows the expert panel to review “the manufacturer’s intended clinical development strategy and proposals for clinical investigation”.³ The JSC, meanwhile, is designed to “exchange information with health technology developers on their development plans for a given health technology” – and, in doing so, facilitate the generation of evidence that meets the likely evidence requirements of a subsequent JCA on that health technology. Both mechanisms will allow the HTD an opportunity to present key planned evidence generation activities, as well as receive critical feedback for fine-tuning of evidence activities to align with the expectations of the eventual clinical evaluation and JCA requirements.

“The opportunity for HTDs to receive parallel JSC and expert advice via a three-way dialogue between the regulators, national HTA bodies, and the HTDs is unprecedented“

The opportunity for HTDs to receive parallel JSC and expert advice via a three-way dialogue between the regulators, national HTA bodies, and the HTDs is unprecedented. JSC uniquely allows HTDs to achieve direct alignment between these stakeholders, overcoming previously siloed engagements. Cooperation is a key tenet under the EU HTAR, with explicit implementation acts to enhance information exchange between the HTA Coordination Group (HTACG) and the expert panel. Achieving early agreement on aspects of evidence generation needed to support both regulatory and HTA processes will help HTDs in prioritizing activities, and potentially the approach and conduct of such activities, in a way that is optimized for all parties.

2) Insights into extent and rigor required for evidence package

As the final JCA report is intended to be used by all EU Member States in their national HTAs, the JCA is expected to be all-encompassing to reflect the local patient populations and the available treatments across all nations. As a result, one of the main concerns that has emerged from the ongoing process for advanced therapy medicinal products (ATMPs) and oncology products relates to the identification of relevant PICOs (Population, Intervention, Comparator[s], Outcome[s]). Out of the six PICO exercises conducted by the JCA subgroup in 2024, three were for medical devices; for these, the number of PICOs identified ranged from one to five.⁵

This may be a new realm for some medical device HTDs, as the requirement to satisfy EU-wide PICOs is not an explicit requirement of current clinical evaluation processes under the medical devices Regulation (Regulation [EU] 2017/745). The issue of multiple PICOs is undoubtedly a big concern among HTDs. Demonstrating the clinical evidence required to address multiple PICOs and meet the requirements of JCA has been raised by HTDs as practical and methodological challenges. It is anticipated that indirect treatment comparisons (ITCs) will see increasing use to estimate effectiveness against comparators where the head-to-head data against the assessed technology are lacking. Thus, getting an early indication of the extent of the PICOs that may apply in the JCA can help HTDs clarify the type of activities needed to bridge any evidential gaps for a successful JCA down the road. JSC provides an opportunity to get this early indication of the potential PICOs.

3) Early planning to facilitate overlapping regulatory and HTA timelines

Currently, HTDs require a conformity assessment to signify that a medical device product meets the EU requirements for safe and effective operation, and a CE marking of conformity (Conformité Européene) is necessary for a medical device to be placed on the market. For select Class IIb or III medical devices, the device must also undergo a central clinical evaluation process to demonstrate safety and efficacy in the intended population under the medical devices Regulation (Regulation [EU] 2017/745) prior to being granted CE marking.³

CE marking does not guarantee local access across the EU. Access pathways for medical devices and HTA processes within these pathways are often ambiguous and varied; in some countries, many different pathways exist. While pricing and reimbursement decision making will remain under the control of individual Member States, a key ambition of the EU HTAR (Regulation [EU] 2021/2282) is to facilitate more timely access of medical devices to patients across Europe. This may require closer alignment and potential some overlap between regulatory and HTA process timelines. JSC can provide insight to the likely timelines and accommodate early planning of activities needed to meet critical regulatory and HTA milestones.

4) Early opportunity to optimize internal capabilities

Lumanity has been helping clients prepare to navigate the potential challenges of the EU HTAR (Regulation [EU] 2021/2282). In discussing our clients’ concerns, it is apparent that close collaboration between different cross-functional matrix teams will be crucial to a successful JCA submission. The JCA dossier requires expert input from medical affairs, regulatory, biostatistics, health economics and outcomes research (HEOR) and value and access teams to establish clear safety and efficacy conclusions that are backed by consistent and scientifically rigorous evidence. We have seen that tailored solutions may involve establishing internal working groups, playbooks, training programs, adapted ways of working, and even the creation of new teams, roles and responsibilities.

Medical device HTDs often work with smaller teams compared with HTDs for medicinal products, which may pose a challenge with the scale and scope of activities required by the EU HTAR (Regulation [EU] 2021/2282). The first wave of JSC is the earliest opportunity for HTDs to evaluate whether their current internal capabilities will be able to meet the demands of an eventual JCA as they assemble the necessary information required for the briefing package. All medical device HTDs should evaluate their EU HTAR readiness; engaging in JSC early is an important litmus to assess if they are able to rise to the challenge.

Conclusion

The EU HTAR is changing the HTA landscape across Europe with many new and unprecedented requirements, particularly for medical devices. In our view, JSC presents a uniquely beneficial opportunity to HTDs operating in the second-largest medical device market globally. By engaging early and gaining an insight into the anticipated scope of a potential JCA and likely timings, HTDs of medical devices can use the JSC to optimize evidence generation planning across regulatory and HTA requirements and, thus, optimize their overall market access strategy.