GSPR: Annex I General Safety and Performance Requirements

1. Key takeaways

The general safety and performance requirements — the GSPR — are the common yardstick against which classification, technical documentation, conformity assessment and post-market surveillance are all measured in Turkey. Because the requirements are numbered, they can be traced clause by clause through every deliverable, and that traceability is what this article helps to build. The sections below map those anchor points and show how a single control table can serve classification, assessment and post-market work at once.

• The carrier of the general safety and performance requirements in Turkey is Ek I (Genel Güvenlilik ve Performans Gereklilikleri). It is the shared baseline of four workstreams: classification, technical documentation, conformity assessment and post-market surveillance.
• Risk management is anchored in point 3 of Ek I. Paragraph 2 of Madde 10 expressly requires manufacturers to establish, document, implement and maintain a risk management system as defined in point 3 of Ek I.
• Points 1 and 8 of Ek I are the common anchor of multiple obligations: paragraph 1 of Madde 61 (acceptability of clinical evidence) and paragraph 1 of Madde 86 (trend reporting) both expressly cite these two points.
• The documentation retention period is 10 years (15 years for implantable devices), counted from the last device placed on the market (paragraph 8 point (a) of Madde 10).
• The general obligations also include Madde 5 (basic requirements for devices used as intended under normal conditions of use) and Madde 6 (devices supplied through information service providers).

2. Legal basis

The provisions and annex points gathered below form a network rather than a list: the annex points state the requirements, while the numbered articles connect those requirements to clinical evidence, trend reporting and post-market reporting duties. The table also notes the parallel obligations of IVD manufacturers under their own regulation.

3. Expert insights

Insight one: Ek I is numbered, and therefore it can be reconciled point by point. Ek I uses a system of numbered points (point 1 through point 23 and onwards). This structure allows the declaration of conformity work to be built as a point-by-point control table: point — applicable or not — location of the evidence file — responsible person. GRZAN recommends making this control table chapter zero of the technical documentation. Placed there, it serves the reviewer before anything else in the file is read, and it tells the whole story of scope decisions before the evidence itself is opened. Because the same table doubles as the evidence index, updates to any single entry immediately show which downstream documents are affected — an effect that manual tracking tends to miss.

Insight two: the repeated citation of points 1 and 8 shows that they are the assessment baseline. Madde 61 cites points 1 and 8 of Ek I when asking whether clinical evidence is acceptable; Madde 86 cites the same two points when setting the threshold for trend reporting. This means the standard for the benefit-risk judgement is unified: enterprises do not need to set different thresholds for different scenarios. One carefully argued benefit-risk conclusion, referenced consistently, serves clinical evaluation, vigilance trend analysis and periodic reporting at the same time, and it keeps the file internally coherent under review. Maintaining that single standard also simplifies training: one benefit-risk rationale, argued once, is easier to keep consistent than a family of scenario-specific thresholds.

Insight three: the retention period moves in step with GSPR updates. Within the retention period required by paragraph 8 of Madde 10, the technical documentation must remain up to date. If the applicable form of the GSPR changes as harmonised standards are updated, the enterprise must reflect that update trajectory within the retention period rather than sealing the file once and forgetting it. A documentation set that is frozen at the date of certification will, years later, no longer demonstrate the conformity it once did. A practical way to achieve this is to schedule a documentation review at every standards update, however minor, and record the outcome even when no change is needed.

4. Practical recommendations

• Build a point-by-point Ek I control table as the navigation page of the technical documentation: point number, applicability judgement, pointer to the evidence, responsible person, date of last update.
• Publish the benefit-risk conclusions on points 1 and 8 as a separate booklet, shared by Madde 61 (clinical), Madde 86 (trend reporting) and Madde 84 (PSUR).
• Use the date-of-last-unit-placed field in the ERP to drive expiry reminders at 10 years / 15 years.
• Assign a named owner for the Ek I control table, so that applicability judgements are periodically reviewed rather than merely stored.

5. Verification checklist

• □ The original text of Ek I has been obtained (a standalone document separate from the body of the Regulation).
• □ The risk management system corresponding to point 3 of Ek I has been established and documented (Madde 10, paragraph 2).
• □ A unified benefit-risk conclusion has been reached on points 1 and 8 of Ek I.
• □ Retention of technical documentation, declaration of conformity and certificates is executed at 10 years / 15 years for implantables.
• □ Within the retention period, a mechanism and responsible persons for continuous updating are in place.

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); the specific point numbers of Ek I are governed by the official annex.

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