Sri Lanka IVD Performance Evaluation Report Requirements

1. Key takeaways

When IVDs are submitted in Sri Lanka under the merged dossier, a performance evaluation test report must be submitted, with content covering both the analytical and the clinical dimensions. In addition, IVDs follow their own independent Class A to D classification system, and only Class A devices that are also non-sterile, non-active, and without measuring functions may qualify for the low-risk pathway. The practical consequence is that IVD projects need their own planning framework from the first day: their evidence profile, their classification logic, and even their reference-country list differ from those of general devices. A team that applies its general-device playbook to an IVD submission will misjudge the evidence required, misjudge the pathway options, and misjudge the reference approvals that strengthen the application. The performance evaluation report, in particular, has no real counterpart in the general-device document set and must be commissioned as a dedicated work package.

• IVDs require a performance evaluation test report covering both analytical and clinical performance, under GL-034, effective 2025-07-23.
• IVDs are classified Class A, B, C, or D under GL-037, effective 2026-05-13.
• The low-risk pathway is limited to listed devices, Class I general devices, and Class A IVDs that are non-sterile, non-active, and without measuring functions.
• The reference-country list for IVDs adds Singapore to the general-device list (industry compilation).

2. Legal basis

The IVD performance evaluation report requirement derives from GL-034, which took effect on 2025-07-23. The IVD classification classes and the low-risk pathway conditions derive from GL-037, which took effect on 2026-05-13. The reference-country observation comes from industry compilation and is noted accordingly. Note how the pieces fit together: the performance evaluation report is the IVD-specific evidence item, the Class A to D classes determine how much evidence the reviewer will expect, and the reference-country list determines which external approvals strengthen the application. Because the classification principle source for general devices is the European Union Medical Device Regulation, teams holding European classification decisions for their IVDs have a natural starting point — but the IVD-specific conditions attached to the low-risk pathway still need to be verified independently, since they add requirements that no European decision alone will answer.

3. Expert insights

Insight one: the analytical plus clinical dual-dimension requirement for IVDs is entirely different from the general-device testing system. General devices are tested for electrical safety, sterilisation, and biocompatibility; IVDs are evaluated for analytical performance (precision, accuracy, detection limit, and similar parameters) and clinical performance (sensitivity, specificity, and similar parameters). The two evidence cultures barely overlap. A laboratory experienced in electrical campaigns will not deliver an IVD performance evaluation, and an IVD trial design will not produce an electrical safety report. Resource planning, vendor selection, and timelines must therefore be built around the IVD evidence profile specifically, not transferred from adjacent product lines. The distinction also runs through the report structure itself: the analytical part and the clinical part must each be presented with their own methods, materials, and results, so that the reviewer can confirm both dimensions have been addressed rather than one being implicit in the other.

Insight two: the overwhelming majority of IVDs cannot use the low-risk pathway. The pathway is open to IVDs only at Class A, and only if the device is simultaneously non-sterile, non-active, and without measuring functions. Testing devices inherently possess a measuring function, which in practice excludes most IVDs. This is a structural exclusion, not an edge case: the very purpose of most IVDs is measurement, so the pathway closes itself for the bulk of the category. Planning teams should assume a standard assessment route for IVDs unless a specific product demonstrably meets all four conditions, and should treat any low-risk assumption as the exception requiring proof.

Insight three: the IVD reference-country list carries one more country than the general-device list — Singapore. This shows that NMRA has adjusted the recognition scope separately for the IVD track, and the general-device reference-country list cannot simply be applied to IVDs. For an IVD manufacturer holding a Singapore approval, this is a directly usable advantage; for a manufacturer relying on approvals from the general-device list alone, the discrepancy can undermine an assumption made at planning time. Checking the IVD-specific list rather than the general-device list is therefore a mandatory step when evaluating reference approvals, and the difference is worth flagging in every project memo that covers both product categories, because the two lists will otherwise be confused exactly when a pathway decision is being made.

4. Practical recommendations

• GRZAN advises IVD clients to perform a two-way confirmation: on one side, confirm the classification class (Class A to D); on the other, confirm whether approvals from recognised reference countries exist, including Singapore.
• Decide the pathway and the budget only after both confirmations are complete, avoiding plans drawn from general-device experience.
• Commission the analytical and clinical parts of the performance evaluation report as one coordinated work package so their conclusions remain mutually consistent.
• Where a Singapore approval exists, flag it early in the dossier, since it expands the reference evidence available to the application.

5. Verification checklist

• □ IVD classification class (Class A / B / C / D) confirmed
• □ Performance evaluation test report (analytical) compiled
• □ Performance evaluation test report (clinical) compiled
• □ Low-risk pathway applicability confirmed (Class A and non-sterile / non-active / no measuring function)
• □ Reference country approval evidence (including Singapore) compiled

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Sri Lanka. Our team prepares dossiers to NMRA expectations, manages submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com