IVDs on a Separate Track: A-D Classification and Performance Evaluation Data

1. Key takeaways

In vitro diagnostic devices are classified in the UAE under an A, B, C, D scheme, which is not the same coordinate system as the Class I–IV scheme for active and non-active devices. Our judgment is that the first task of an IVD project is still to obtain the EDE classification letter, because the class depends on three elements: the purpose of the test, the subject of the test and the consequence of an erroneous result. The same technology platform used for screening and used for diagnosis lands in different classes, and applying the classification conclusions of the country of origin or the EU directly carries a real risk of misalignment. Article 2 brings medical devices within the scope of medical products, and the mandatory marketing authorization requirement of Article 5 applies to IVDs just as it does to devices.

• IVDs are classified under a separate A, B, C, D scheme; the Class I–IV device coordinates do not transfer.
• The class depends on the purpose of the test, the subject of the test and the consequence of an erroneous result, so the same platform can land in different classes for screening and for diagnosis.
• Article 2 brings medical devices within the scope of medical products, and the Article 5 requirement of a marketing authorization applies to IVDs.
• The classification letter, issued within 10 working days, fixes the class before performance data are assembled, avoiding rework for high-risk products.

2. Legal basis

The IVD framework rests on Articles 2, 5 and 6 of Federal Decree-Law No. 38/2024 and on the EDE classification service page, summarised below.

3. Expert insights

Insight 1: Three elements decide the class, and the consequence of an erroneous result is the one most often underestimated. The purpose of the test fixes the attribute of the use; the subject of the test fixes the exposed population; the consequence of an erroneous result fixes where the risk lands. Our judgment is that infectious disease screening, blood grouping and tissue typing products fall into the higher classes because an erroneous result causes direct public health or individual harm, while a research-use product built on the same principle sits outside this coordinate system entirely. Treating identical technology as an identical class is the most common source of misalignment in IVD filings.

Insight 2: Performance evaluation data are organised differently from clinical evidence. The core evidence of an IVD has two parts, analytical performance and clinical performance: precision, sensitivity, specificity, limit of detection, interference and stability constitute the analytical part, while clinical sensitivity and clinical specificity constitute the clinical part. We present the two parts separately and map each to the intended use claims one by one, avoiding repeated round-trips at the stage where data exist but cannot be matched to a claim. This shares a root with the safety and effectiveness data logic for Class III and IV devices, but the shape of the evidence differs.

Insight 3: For an IVD, the labelling and instructions for use are part of the evidence, not packaging accessories. Article 6(1)(g) requires that the inner and outer packaging and the paper or electronic instructions for use be complete in information and conform to the EDE labelling guidance, and the EDE classification service page likewise lists the instructions for use and the packaging label artwork among the documents due at the classification stage. Our approach is to write the reagent components, sample types, storage conditions, result interpretation and limitations into the instructions for use already at the classification stage, leaving the filing stage only a consistency check rather than a rewrite. The Executive Regulations under the Decree-Law have not yet all been issued, and questions on the detail of the A–D scheme and the range of performance data are settled by written confirmation from EDE.

4. Practical recommendations

• Submit the classification application at project initiation, lock the A–D class with the classification letter issued within 10 working days, and only then start organising the performance data.
• Self-check the classification against the three elements of test purpose, test subject and consequence of error, without directly applying the conclusions of the country of origin or reference authorities.
• Organise the performance evaluation data in two parts, analytical and clinical, mapped claim by claim to the intended use.
• Finalise the instructions for use at the classification stage, covering reagent components, sample types, storage conditions, result interpretation and limitations.
• Prepare the label artwork in bilingual versions for inner and outer packaging according to the EDE labelling guidance, keeping the wording consistent with the instructions for use.
• For IVDs with software-based interpretation, prepare the algorithm and software version descriptions in parallel, and bring version changes into the Article 15 change management assessment.

5. Verification checklist

• □ The EDE classification letter has been obtained, stating the A, B, C or D class of the IVD and whether a marketing authorization is required.
• □ The basis of the classification is recorded in writing against the three elements of test purpose, test subject and consequence of error.
• □ The analytical performance data, covering precision, sensitivity, specificity, limit of detection, interference and stability, are complete.
• □ The clinical performance data map claim by claim to the intended use and are traceable to the original studies.
• □ The instructions for use and the inner and outer packaging label artwork conform to the EDE labelling guidance, with the bilingual versions consistent.
• □ The algorithm and version descriptions of software-interpreted products are included, and a change management mechanism is in place.
• □ Written confirmation from EDE has been obtained on the detail of the A–D scheme and the range of performance data.

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team manages MOHAP registration applications, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com