Stakeholder Reflections on the Draft EU JCA MD Implementing Regulation

Introduction

At the start of this year, and every 2 years thereafter, selected medical devices (MDs) and in vitro diagnostic devices will be subjected to the Europeans (EU) Joint Clinical Assessment (JCA).¹ Given the likely significant impact the process, and imminent final Implementing Regulation and JCA dossier template – both expected to be introduced later this year – will have, the European Commission launched a public consultation on the draft Implementing Regulation and the proposed JCA template in June.²

In this article we analyze the main points of contention raised by stakeholders during the consultation period and assess their likely impact for health technology developers (HTDs) should these points persist in the final Implementing Regulation.³

Lumanity’s comments

As part of our continued commitment to help shape the evolving EU landscape, Lumanity responded to the public consultation with a focus on the following key areas of concern:

• Selection criteria and authority: greater clarity is needed on the circumstances under which the European Commission may select MDs for JCA, including rationale for when these devices were not selected by the Coordination Group (CG) and how the proposed selection criteria will be applied
• Communication with HTDs: to support effective planning and resource allocation, timely and transparent communication regarding the criteria and selection process is essential
• Timelines: triggering the JCA process immediately following the issuance of the certificate of conformity contradicts the possibility of assessments after market placement that was previously noted in Regulation 2021/2282⁴

In our view, clarification on these points is essential to informing how HTDs interact with the CG throughout the assessment process and manage the JCA pathway, alongside other Member State-specific regulatory and HTA processes.

Comments from other parties

In addition to our submission, 27 other responses were provided by a range of stakeholders from across Europe. In summary, lack of transparency, tight timelines, and the need for meaningful stakeholder involvement were areas of concern. Below we consider the possible implications should these remain unaddressed.

Lack of transparency in the selection of MDs to undergo JCA

There was broad agreement that the reasoning for selecting MDs subject to a JCA remains unclear. While the regulation stipulates a list of criteria, there was little explanation on how these will be applied by the CG and the European Commission. Additionally, the roles of the CG and the European Commission remains unclear, with conflicting responsibilities. While the CG is primarily responsible for making the recommendation, the European Commission may also select MDs independently.

This lack of transparency contributes to continued unpredictability for HTDs, potentially disrupting launch planning and delaying patient access to critical devices. In cases where the Commission reverses a non-recommendation by the CG, HTDs may have significantly less time to prepare.

From HTD:

“…The implementing regulation remains very opaque on this topic of criteria, process and timings for selection of devices for JCA, and it doesn’t offer any predictability for HTDs, making it very difficult to appropriately prepare for potential JCA…”

What is the current implication for  HTDs?

• Early scenario planning: evaluate the access and reimbursement pathways under both JCA and non-JCA scenarios and identify key go/no-go milestones. If the MD meets any of the selection criteria, prepare contingency measures to support the generation of data required and any potential alternative strategies needed well in advance the pre-launch phase
• Participate in Joint Scientific Consultations (JSCs): engage in JSCs to gauge likelihood of a product undergoing an eventual JCA. This will help align the overall launch strategy and evidence generation activities with anticipated JCA requirements

Tight and impractical timelines:

Responders felt the timeframe for submitting the JCA dossier – from the receipt of CE marking – is challenging for HTDs in the context of existing approval processes under EU Regulation 2017/745.⁵ While this concern relates to medicinal products (MPs), unlike MPs, clinical evidence likely to be required for MD JCAs are typically collected post-launch. The short timeframe between the CE certification to the submission deadline in the draft Implementing Regulation is approximately 6 months – too short for HTDs to generate such evidence. In particular, concerns about the utility of the JCA dossier for decision-making, with the lack of more robust evidence typically generated post-launch, were raised. Guidance on how the JCA process will accommodate post-launch evidence remains limited, despite its critical role in the overall evidence package for MDs compared with MPs.

These suggested timelines may risk a delay in reimbursement in Europe, potentially impacting patient access to MDs and disincentivizing MD and MedTech innovation.

Tentative timeline for draft Implementing Regulation

From Business Association:

“This timeline is highly compressed and misaligned with the realities of HTDs. Most clinical effectiveness data only become available post-launch. If the evidence is not available, HTDs may be forced to initiate new clinical studies within unrealistic timeframes – an approach that is resource-intensive, unfeasible for most device developers, and will ultimately further delay access to new innovations for European patients.”

What is the current implication for  HTDs?

• Reassess data sources for evidence development: HTDs may need to consider other sources of data to generate comparative effectiveness, given that the proposed timeline means post-launch evidence is unlikely to be available for the JCA dossier. Other than clinical trials, real-world evidence could augment the overall evidence package
• Adapt regulatory and launch strategies to meet evolving requirements: to fulfil the requirements of the CE conformity assessment and JCA, HTDs may need to rethink regulatory and launch timelines. Activities should be streamlined to maximize efficiency and synergy

Meaningful involvement for all stakeholders

Responders also highlighted the need for more structured, consistent involvement of diverse stakeholders throughout the JCA process, including patients, clinicians, scientific organizations,  and HTDs. While Article 10 of the Draft Implementing Regulation provides an opportunity for involvement, engagement mechanisms remain vague and undefined.²

From Patient Organization:

“…the current draft is mentioning for the consultation of stakeholder organizations during JCAs and the assessment scope proposal ‘At specific steps and timeframes’ … is much too vague… Greater detail is needed to ensure transparency, predictability, and meaningful engagement of patient experts throughout the process.”

From Scientific Organization:

“…“Early, structured engagement with diverse stakeholders would ensure that JCAs are clinically relevant, patient-centered, and aligned with real-world healthcare needs, while also allowing stakeholders to propose appropriate experts to contribute to the assessments.”

Furthermore, opportunities for HTDs to contribute during the scoping phase – where Population, Intervention, Comparator(s), Outcome(s) (PICOs) are confirmed – remain limited. Given the unique evidential challenges that MDs face, this input is essential for contextualizing the intended use, therapeutic positioning, and evidentiary constraints. This was illustrated by several responders, who explained that their exclusion from past EUnetHTA pilots had led to assessments with limited contextual insight, restricted PICOs, and selective evidence use.

From Trade Association:

“Defining PICOs that are relevant for healthcare systems and patients and that can be addressed by HTDs in the timeframe of the assessment is crucial to produce valuable JCA reports… if a technology becomes selected for JCA, most likely there would not have been a real opportunity for HTDs to discuss expectations in terms of evidence generation and relevant PICOs with assessors and HTA bodies. This makes the involvement of the HTD at the beginning of the scoping phase even more relevant.”

What is the current implication for  HTDs?

• Robust stakeholder engagement: during launch it is increasingly vital to foster buy-in and build familiarity with the MD across a wider range of stakeholders, including patient/patient organizations, clinicians, and scientific organizations. Patients’ perspectives substantiate claims of unmet medical needs and the clinical value of MDs

Conclusion: a chance to get this right

Based on the rolling plan, last updated in June 2025, we expect final JCA guidance for MDs as we reach the end of Q3 this year. Adoption of the final Implementing Regulation is expected by Q4.

Following this, should concerns persist, HTDs will need to reassess timelines and strengthen their internal coordination. Combined with earlier patient and healthcare professional engagement to generate evidence, HTDs can still meet JCA expectations and achieve successful market access.