Clinical Evaluation and the CER: Annex XIV

1. Key takeaways

Clinical evaluation is often reduced to a report, and that reduction is the root of many filing defects. Under the Turkish Regulation it is a planned, executed and documented activity spanning the whole life of the device. The points below identify the statutory basis, the manufacturer’s discretion over evidence levels, and the special gate that applies to high-risk products before any clinical work begins. The article gathers the provisions that define the activity, the discretion the manufacturer holds over evidence levels, and the additional gate for high-risk classes — three elements that together determine both the cost and the calendar of a filing.

• Clinical evaluation is a complete activity of planning, execution and documentation, not a single report. Paragraph 1 of Madde 61 requires the manufacturer to plan, conduct and document a clinical evaluation in accordance with that article and Part A of Ek XIV.
• The level of clinical evidence is set by the manufacturer, who must justify it. Paragraph 1 of Madde 61 states expressly that the manufacturer determines and justifies the level of clinical evidence needed to demonstrate conformity with the general safety and performance requirements; that level must be commensurate with the characteristics of the device and its intended purpose.
• Class III devices and those Class IIb devices referred to in point (b) of paragraph 1 of Madde 54 face an additional preliminary step before the clinical evaluation and/or clinical investigation (paragraph 2 of Madde 61). This is an extra constraint on high-risk products.
• The data basis of the clinical evaluation includes an assessment of the acceptability of the undesirable side effects referred to in points 1 and 8 of Ek I and of the benefit-risk ratio.

2. Legal basis

Two regulations define the evidential framework: the Medical Device Regulation, which governs clinical evaluation for devices, and the IVD Regulation, which substitutes performance evaluation for in vitro diagnostics. The table below records both instruments with their official references and the provisions relied upon in this article.

3. Expert insights

Insight one: a commensurate level of clinical evidence can be self-determined, but it must leave a trace. The Regulation hands the determination of the evidence level to the manufacturer, and the price of that discretion is the duty to argue it. This constitutes a point that the notified body and the Kurum can challenge: if the CER contains only a statement that literature was searched, without explaining why that literature is sufficient to support the intended purpose, the chain of argument is broken. The justification must connect device characteristics, intended purpose and the type of evidence chosen, so that the reviewer can follow every link from claim to source. A well-built justification reads the evidence level downwards and upwards with equal care: it explains why less is sufficient where the device is simple, and why more is proportionate where the risk profile is higher.

Insight two: the high-risk preliminary step of paragraph 2 of Madde 61 is frequently underestimated. For Class III and certain Class IIb products, a procedure driven by point (b) of paragraph 1 of Madde 54 stands before the clinical evaluation. Treating it as optional forces the project to be rescheduled at a late stage. The consultation route affects timing, resourcing and the entire documentation calendar, so discovering it late does not merely delay one task — it reorders the plan that every other task depends on. Because the preliminary step involves external interaction, its duration is the least controllable variable in the plan, which is precisely why it belongs at the front of the schedule rather than the middle.

Insight three: IVDs follow performance evaluation, not clinical evaluation. The corresponding provision of the IVD Regulation is Madde 58, and the operative term is performance evaluation. Applying a CER template to an IVD project is visible to the reviewer at first glance as a mismatched system. The terminology, the structure and the evidence conventions differ, and a file that borrows the wrong vocabulary invites questions about whether the underlying analysis was ever properly framed. Alignment here is cheap at the template stage and expensive afterwards, so confirm the terminology before writing begins rather than at review.

4. Practical recommendations

• Open the CER with a dedicated chapter on the justification of the level of clinical evidence, stating the correspondence between device characteristics, intended purpose and the type of evidence selected.
• For Class III and the relevant Class IIb projects, schedule the preliminary procedure of paragraph 2 of Madde 61 into the Gantt chart before technical documentation work begins.
• Use the performance evaluation terminology (performans değerlendirmesi) consistently across IVD projects.

5. Verification checklist

• □ The planning, execution and archiving of the clinical evaluation have been completed under Madde 61 paragraph 1 and Part A of Ek XIV.
• □ The selected level of clinical evidence has been justified in writing as commensurate with the device characteristics and intended purpose.
• □ Class III devices and the Class IIb devices referred to in point (b) of paragraph 1 of Madde 54 have completed an assessment of the preliminary procedure.
• □ The benefit-risk conclusions have been made against points 1 and 8 of Ek I.
• □ IVD projects have switched to performance evaluation terminology and do not reuse the CER template.

Regulatory information verified to 29 October 2026. The provisions listed in this article were checked against the current text on the Turkish legislative information system (MevzuatNo 38657 and 38658).

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