By Swetha Sankar | Tue Jul 1 2025 | 2 min read

Table of Contents

If you're preparing for EU IVDR compliance, one section should be at the center of your technical file strategy: Annex I — General Safety and Performance Requirements (GSPR).

The GSPR under Regulation (EU) 2017/746 is not just a checklist. It’s the foundation of your entire conformity assessment—every risk control, label, clinical claim, and post-market procedure maps back to it.

What Is the GSPR in IVDR?

Annex I of IVDR lists 20 overarching clauses, most of which contain sub-requirements, covering every stage of the device lifecycle.

These requirements apply to:

  • All IVD classes (A to D)
  • All economic operators in the EU supply chain
  • All routes to conformity, whether or not a Notified Body is involved

Unlike the old IVDD, you must now demonstrate conformity to each relevant GSPR clause with objective evidence.

What’s in the GSPR?

The IVDR Annex I GSPR is structured into three chapters:

  • Chapter I — General Requirements (Clauses 1–9)
  • Device must be safe and effective under normal and abnormal use
  • Risk management must reduce risks "as far as possible" (AFAP)
  • Design must align with state of the art
  • Benefits must outweigh residual risks

> Evidence: Risk analysis file (ISO 14971), design validation reports, and clinical performance data.

  • Chapter II — Design and Manufacturing Requirements (Clauses 10–20)

Includes:

  • Chemical, biological, and physical properties
  • Elimination of contamination risks
  • Software validation, if applicable
  • Device stability, transport, and packaging
  • Accuracy, analytical sensitivity/specificity
  • Safe disposal and environmental risk minimization

> Evidence: Biocompatibility tests, software lifecycle documentation (IEC 62304), labeling on hazardous content, shelf-life validation.

  • Chapter III — Labeling and IFU Requirements (Clause 21–22)
  • Devices must be clearly labeled with UDI, CE mark, and relevant warnings
  • IFU must include:
    • Intended use and user profile
    • Device limitations
    • Test procedure and performance metrics
    • Storage and handling instructions
    • Manufacturer/importer details

> Evidence: Full label/IFU artwork in every EU language, traceability system to UDI database.

GSPR vs. IVDD Essential Requirements: What Changed?

GSPR vs. IVDD Essential Requirements.PNG

> Under IVDR, even Class A devices must meet the full set of applicable GSPRs and justify any non-applicable clauses.

How to Prove GSPR Compliance

Notified Bodies and authorities now expect:

  1. A GSPR Checklist Matrix
    • All 20 clauses (and subpoints) listed
    • Indicate applicability (Yes/No)
    • Reference to the exact document or section proving compliance
  2. Cross-linked Evidence File
    • Each claim in the checklist must map to an actual annexed file
    • Traceability must be auditable
  3. Performance Evaluation Integration
    • GSPR ties directly to your PER (Annex XIII)
    • E.g., Clause 9 on clinical performance must cite PER results

Common Mistakes in GSPR Submissions

  • Copy-pasting IVDD Essential Requirements checklist
  • Declaring “Not Applicable” without justification
  • Missing evidence for software validation (Clause 16.2)
  • Omitting UDI system details for labeling compliance
  • Submitting evidence in the wrong language or format

> GSPR non-compliance is one of the top three reasons for IVDR certification delays.

GSPR Is Not a Checklist—It’s a System

Each GSPR clause links to:

  • Risk Management (ISO 14971)
  • Design Verification (Annex II Section 6)
  • Clinical & Analytical Performance Data (Annex XIII)
  • Post-Market Surveillance (Annex III)
  • UDI/EUDAMED requirements

This is why IVDR GSPR is often called a "compliance spine" every other documentation thread connects to it.

How Acquis Simplifies GSPR Mapping

With Acquis, you don’t have to manually build GSPR matrices and chase documents across your organization.

Our platform automates:

  • Pre-built GSPR checklists aligned to IVDR Annex I
  • Smart linking of evidence files to GSPR subclauses
  • Automatic PMS/PMPF integration for ongoing compliance
  • Audit-ready packaging of all GSPR-linked content
  • Multilingual IFU and label support, UDI-ready exports

Book your IVDR GSPR Audit-Readiness Review and reduce your documentation time by up to 60%.

Topics

EU MDR

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IVDR GSPR Explained: How to Meet Annex I Requirements Without Missing Anything

GSPRs (General Safety and Performance Requirements) in Annex I of Regulation (EU) 2017/746 set the baseline safety, performance, and labeling standards for all IVD devices (Classes A–D) marketed in the EU/EEA. Compliance with GSPRs is mandatory for CE marking and regulatory approval.
Annex I is structured into three chapters: General requirements (clauses 1–9) – covering risk management, benefit-risk balance, and device safety. Design and manufacture (clauses 10–19) – covering chemical, biological, electronic, and mechanical risks. Information supplied with the device (clause 20) – covering labeling, UDI, user instructions, and packaging.
Under Annex II of IVDR, technical documentation must map each applicable GSPR clause to: A justification of applicability, Methods used to demonstrate conformity (e.g. testing reports, standards), Harmonized standards or Common Specifications applied, Document evidence location (traceable in QMS or technical file).
Yes. IVDR requires analytical performance data for all devices. Clinical performance must be demonstrated via performance studies or literature unless justified otherwise—especially for Class C and D devices. MDCG 2025‑5 provides guidance on study types and documentation.
Yes, under Article 5.5, health institution–manufactured IVDs must still comply with Annex I GSPR—even for LDTs used within the same legal entity—ensuring documented risk management and safety evidence.
General risk reduction and state-of-the-art design (Ch. I) Chemical and microbial safety, software validation, and interoperability (Ch. II) Accurate labeling, inclusion of UDI, and clear user instructions (Ch. III)
Common issues include incomplete GSPR mapping, insufficient clinical evidence, missing justification for non-applicable clauses, and inadequate traceability in technical documentation. A structured risk-based compliance workflow is essential.