EU IVDR General Safety and Performance Requirements under Annex I

1. Key takeaways

The General Safety and Performance Requirements (GSPR) are the technical floor of the IVDR and are set out in Annex I. Article 5(2) requires devices to satisfy the GSPR that apply to them, taking account of the intended use; Article 5(3) further requires that the demonstration of conformity with the GSPR include the performance evaluation carried out under Article 56. Annex I is organised in three chapters: Chapter I contains the general requirements, including performance characteristics; Chapter II contains the requirements on design and manufacture; and Chapter III contains the requirements on labelling and instructions for use.

In practice, the GSPR operate as an applicability matrix: for every numbered requirement, the manufacturer must state whether it applies, justify any exclusion, and point to the evidence. Because Section 9 of Annex I also anchors the common specification for Class D devices, the GSPR are where classification, evaluation and general-specification compliance all converge.

2. Legal basis

The table below lists the provisions on the GSPR, the performance characteristics and the common specification that targets them.

Note the two dates for Implementing Regulation (EU) 2022/1107: adopted on 4 July 2022 and applying from 25 July 2024. The application date is the operative one for Class D submissions.

3. Expert insights

Insight 1: the GSPR are a matrix of applicability judgment and clause-by-clause argument, not a checklist to tick.

Article 5(2) requires satisfaction of the GSPR that are applicable to the device. The standard approach in technical documentation is a conformity matrix: list the GSPR clause by clause, give the reason for applying or not applying each one, identify the evidence file (test reports, standards, literature) and state the conclusion. Exclusions left without a justification are among the most frequent sources of notified body nonconformities, because the reviewer cannot distinguish a considered exclusion from an oversight and must raise a finding either way.

Insight 2: Section 9 is the IVD-specific performance requirement, and the landing point of the common specification.

Section 9 of Annex I sets the performance characteristics requirements: 9.1(a) analytical performance, 9.1(b) clinical performance, 9.3 reference measurement procedures for calibrators and control materials, and 9.4(a) devices for self-testing intended for lay users are exactly the four groups covered by the common specification in Implementing Regulation (EU) 2022/1107. Class D products must, from 25 July 2024, be assessed against the common specification or against a documented argument of equivalence. Drafting that equivalence argument early avoids late-stage rework of the performance evaluation file, which is otherwise the slowest document to regenerate.

Insight 3: risk management and usability run through the whole Annex.

Article 10(2) requires a risk management system in accordance with Annex I Section 3. Elsewhere Annex I touches stability, software life cycle, electromagnetic compatibility, mechanical and electrical risks, and protection against infection and microbial contamination. Treating risk management as a static table, disconnected from performance evaluation and post-market surveillance data, is the second most common nonconformity in practice. The risk file should absorb field data and PMPF results continuously, with hazard conclusions revisited whenever new performance evidence arrives.

Insight 4: the Section 20 labelling and instructions requirements connect directly to the language duty in Article 10(10).

Article 10(10) requires the accompanying information to be in the official language or languages of the Member State where the device is provided, as determined by that Member State; information for self-tests and near-patient devices must be readily understandable to the intended user. When marketing across several countries, language version management belongs inside change control, so that every label revision propagates to all required language versions and the technical documentation index, rather than emerging late as a translation backlog that becomes a nonconformity.

4. Practical recommendations

1. Build a GSPR conformity matrix with six columns: clause, applicability, reason, evidence, conclusion and owner.
2. Organise performance evidence along Annex I Section 9: analytical performance, clinical performance, stability and calibration traceability each in its own volume.
3. For Class D products, verify item by item against the common specifications of (EU) 2022/1107 and document any equivalence arguments separately.
4. Create cross-references between the risk management file, the performance evaluation report and PMS data.
5. Bring language versions and label templates under change control, updating the technical documentation index with every revision.

5. Verification checklist

• □ A conformity matrix covering all Annex I clauses established under Article 5(2)
• □ Non-applicable clauses justified in writing, not left blank
• □ Section 9 performance evidence filed by group: analytical, clinical, stability, traceability
• □ Class D products verified against (EU) 2022/1107 (applying from 2024-07-25)
• □ Risk management (Annex I Section 3) cross-referenced with performance evaluation and PMS
• □ Label and instructions language versions under change control (Article 10(10))

Regulatory information verified as of 29 October 2026.

GRZAN constructs GSPR conformity matrices for IVDR technical documentation, prepares equivalence arguments against the common specifications of Implementing Regulation (EU) 2022/1107, and integrates risk management with performance evidence for the EU IVDR market. For tailored compliance support, contact info@grzanglobal.com.