EU Joint Clinical Assessment Is Starting: Is Your CER Ready for PICO?
EU Joint Clinical Assessment Is Starting: Is Your CER Ready for PICO?
Your Clinical Evaluation Report (CER) proves your device is safe and performs as claimed. What if a reviewer now asks whether it works better than the alternatives?
That is the question behind the EU's Joint Clinical Assessment (JCA), and it is starting to move from planning to practice. A CER does not answer it. If your pipeline includes a high-risk device, your evidence plan needs to answer it early.
What changed this week?
On 2 October 2026, a European MedTech roundup reported that national health authorities and notified bodies had opened initial operational workflows for high-risk devices preparing for centralised EU-wide clinical assessment. That is a signal of preparation, not proof that submissions are open at scale.
The legal base is Regulation (EU) 2021/2282 on health technology assessment, which applies from 12 January 2025. The Commission also lists an implementing act for devices and in vitro diagnostics (IVDs). Please check that text for the exact procedure.
Which devices are in scope?
Not every high-risk device will be assessed. According to a May 2026 analysis by Simon-Kucher, a device must first go through expert panel review during CE certification. Then a further selection decides which devices are assessed.
The device types that can be selected are:
- Class III implantable devices
- Class D IVDs
- A subset of Class IIb devices: active devices that administer or remove medicinal products (ARMP)
Selection criteria include unmet medical need, first-in-class status, impact on patients or health systems, use of AI, and cross-border relevance. The same source expects only around five device JCAs in 2026, with a gradual ramp-up. Even so, a first-in-class implant is a likely candidate.
How is a JCA dossier different from a CER?
A CER shows that your device meets the MDR's safety and performance requirements and has an acceptable benefit-risk balance (MDR Article 61 and Annex XIV). A JCA dossier compares your device with named alternatives.
PICO stands for Population, Intervention, Comparator and Outcomes. The same source says the dossier must show relative effectiveness and safety against relevant comparators, and that the comparator is set at EU level through the PICO process.
| CER (MDR) | JCA dossier | |
|---|---|---|
| Core question | Is the device safe, and does it perform as claimed? | Is it better, or safer, than the alternatives? |
| Comparator | Mostly state of the art and equivalent devices | A defined comparator set through PICO |
| Evidence focus | Safety, performance, benefit-risk | Relative effectiveness and safety |
| Result | Input to CE certification | One EU-level report for national HTA bodies |
The JCA report is not a reimbursement decision. National bodies should consider it, but pricing and reimbursement stay national.
Why can't you fix gaps after submission?
The process has fixed timelines and little room to iterate. Simon-Kucher warns that evidence gaps are hard to close after submission.
Our view is simple. A missing comparator study takes years, not months. If you only learn about the gap at CER-drafting time, it is too late to generate that evidence.
What should you do about evidence planning now?
Picture a Class III implant due for CE marking in 2028. Its pivotal study is single-arm, because that was enough for the CER. A JCA reviewer asks for comparative data against current practice, and the study cannot supply it.
To avoid that, we suggest four steps:
- Screen your pipeline. Mark devices that could meet the scope and selection criteria.
- Draft likely PICOs. Define your population, the probable comparators and the outcomes that matter to patients.
- Test your study design. Check whether planned studies can support a comparison. Add a comparator arm or an indirect comparison if not.
- Use early advice. Joint Scientific Consultations, running since 2025, let manufacturers discuss comparators and study design with Member States.
A living CER, as we discuss in our article on the MDR reform, helps with the first three steps. It does not replace comparative evidence.
Key takeaways
- JCA is a new EU-level assessment, separate from the CER and from CE marking.
- Only some high-risk devices will be selected: Class III implantables, Class D IVDs and certain Class IIb devices.
- The dossier is built around PICO and compares your device with alternatives.
- Comparator gaps are hard to fix after submission, so plan the evidence during clinical development.
- Audit your pipeline for JCA scope now, not when the CER is being drafted.
FAQ
Does JCA replace the CER?
No. The CER remains part of MDR conformity assessment. JCA is an additional EU-level assessment for selected devices.
Will every Class III device get a JCA?
No. Only devices that go through expert panel review can be considered, and further criteria apply.
Does a JCA decide reimbursement?
No. It produces one clinical assessment report that national HTA bodies should consider, while reimbursement remains national.
What is a Joint Scientific Consultation?
It is an EU-level mechanism for manufacturers to discuss evidence strategy, including study design and comparators, before submission.
Not sure whether your pipeline falls under JCA? Contact the Qmedify Regulatory Team and we will help you map the evidence you need.