Clinical Evaluation Report Requirements in Jordan

1. Key takeaways

In Jordan, the clinical evaluation report (CER) is a requirement tiered by risk class: Class III devices must submit a clinical evaluation report; Class IIb products generally need to provide clinical evidence; Class I products can generally be exempted from clinical data, but must declare conformity with the essential safety and performance requirements (practical estimate). GRZAN’s conclusion is that the tiering logic matches the European one, so a CER already produced for Europe can serve directly as the basis of the Jordanian dossier.

• Second conclusion: the reference-country reliance mechanism applies to clinical evidence as well. For products holding CE or FDA approvals, the conclusions of the clinical evaluation already completed are accepted by the JFDA with a comparatively high probability.
• Third conclusion: Jordan does not universally require local clinical trials. As for the industry claim that clinical data from medical institutions in the Middle East region must be provided, GRZAN has found no corresponding official regulatory source and treats it as a practical estimate — before submission, companies should confirm the specific requirement with the JFDA through the AR.

2. Legal basis

The clinical evaluation and clinical data requirements for registration in Jordan are anchored in the instruments listed below, each shown with its reference, publication date and the location of the relevant provisions.

Provision numbers are subject to the Arabic originals published in the Jordanian Official Gazette and issued by the JFDA; the specific thresholds within the tiered requirements are practical estimates.

3. Expert insights

The observations below reflect GRZAN’s work adapting EU and US clinical evaluation reports to the Jordanian submission format.

Insight 1: the hierarchy of evidence matches international practice. The sources of clinical evidence for a clinical evaluation usually include: clinical studies of the device under application itself, literature data on similar devices already on the market, and clinical data on equivalent devices. The way evidence is organised in a CER produced in the EU under MEDDEV 2.7.1 or MDR Annex XIV can be carried over directly to Jordan. The three sources are combined in proportion to what the device class and the available data actually support.

Insight 2: the acceptability of the equivalence argument depends on the transparency of the evidence. If the CER relies on data from an equivalent device, it must fully disclose the identification of the equivalent device, the comparison table of its technical, biological and clinical characteristics, and the argument for the accessibility of the data. GRZAN recommends completing the equivalence comparison in full rather than presenting only the conclusion. Where the comparison is complete, equivalence rarely becomes the point of failure; where it is thin, it almost always does.

Insight 3: reference-country approval can significantly reduce supplementary demands on clinical evidence. For products holding CE or FDA approvals, the clinical evaluation has already been examined under the supervision of the reference-country regulator. The JFDA accepts these conclusions, and the probability that the CER will be met with a demand for additional local data falls (practical estimate). This reliance is precisely why the reference-country approval documents belong at the front of the dossier.

Insight 4: clinical evidence for IVDs has its own dimension. Beyond clinical performance, IVDs must also provide analytical performance data — precision, accuracy, detection limit, linear range, interference and cross-reactivity, and so on. This evidence structure differs from that of therapeutic devices. Separating the two performance strands prevents reviewers from asking clinical questions of analytical data, and the reverse.

Insight 5: JFDA’s internationalisation path will raise the evidence standards. The JFDA has listed the acquisition of ICH membership among its 2025–2027 priorities. The introduction of ICH standards will raise the requirements for how clinical evidence is organised, which is good news for companies that have already compiled their CER to international norms. The preparation done now therefore continues to pay off after membership is achieved.

4. Practical recommendations

• First, reuse the existing EU or US CER. Building on the existing CER, add the description of local use scenarios and the reference-country approval information. The additions are incremental, which keeps the cost of adapting the CER low.
• Second, complete the equivalence argument in full. A complete comparison table markedly lowers the probability of challenge from the JFDA. Completeness is judged on the comparison table itself, not on the narrative around it.
• Third, confirm the specific thresholds of the tiered requirements through the AR. The clinical evidence requirements for the different risk classes show elasticity in practice, so confirming them before submission avoids rework (practical estimate). A single confirmation through the AR settles the question definitively before resources are committed.
• Fourth, prepare the analytical performance data package separately for IVD products. Analytical performance and clinical performance should be presented separately. The separate package also survives reuse in other markets that apply the same split.

5. Verification checklist

• □ The tiered requirements for clinical evidence have been confirmed against the risk class
• □ The EU or US CER has been reused and supplemented with the local use scenario description
• □ The equivalence comparison table is complete (technical, biological and clinical dimensions)
• □ Whether additional local or regional clinical data are needed has been confirmed through the AR (practical estimate)
• □ A separate analytical performance data package has been prepared for the IVD products
• □ The reference-country approval documents have been placed at the front as the basis for accepting clinical evidence
• □ The cited provision numbers have been re-verified against the Arabic text of the Official Gazette

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Jordanian market. Our team prepares JFDA-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com