EU IVDR Technical Documentation under Annex II: Structure, GSPR Matrix and Traceability

1. Key takeaways

Technical documentation is the primary evidence package for IVDR compliance. Under Article 10(4), the manufacturer must prepare and continuously update the technical documentation in a way that allows the assessment of the conformity of the device with the Regulation, and the documentation must contain all of the elements set out in Annex II and Annex III. This is not a one-off drafting exercise: the obligation to keep the documentation current runs for as long as the device remains on the Union market, and every material change to the device, its intended purpose or its manufacturing process must be reflected in the file.

Retention is equally binding. Article 10(7) requires the manufacturer to keep the technical documentation available for the competent authorities for at least 10 years after the last device has been placed on the market. The Commission may further amend the content requirements for the technical documentation by means of delegated acts in order to take account of technical progress, as provided in the second subparagraph of Article 10(4). In practical terms, the file is a living instrument: its structure, its evidence links and its update triggers should be designed on day one, because a documentation system that cannot absorb change will fail at the first notified body or competent authority review.

2. Legal basis

3. Expert insights

Insight 1: The six sections of Annex II form a closed loop linking the product, the evidence and the judgement.

The backbone of Annex II is: (1) description and specification of the device, including variants and accessories; (2) information to be supplied by the manufacturer, meaning the label and the instructions for use; (3) information to be supplied in the design and manufacturing file; (4) the general safety and performance requirements (GSPR); (5) benefit-risk analysis and risk management; and (6) device verification and validation. Reviewers concentrate their effort on sections (4) and (5), because these are the sections where a claim made elsewhere in the file is tested against structured evidence. A file that reads well but cannot demonstrate the chain from specification to risk control to validation data will generate questions round after round. Building the loop deliberately, with cross-references between the sections, is the single most effective way to shorten an assessment.

Insight 2: The GSPR section must be built as an applicability matrix, not as a list of standards.

Section 4 of Annex II requires the manufacturer to set out, requirement by requirement, which GSPR apply, the method used to demonstrate conformity, and the conclusion reached. Requirements that are judged not applicable must be supported by a justification. Reviewers expect the matrix to show, for each row, the evidence document and its version, so that the conclusion can be traced back to a test report or a design record. Where harmonised standards are cited, the manufacturer must check the current harmonised version listed in the Official Journal of the European Union (OJEU); where common specifications (CS) are cited, the class-specific applicability must be checked against (EU) 2022/1107, which addresses Class D devices. A matrix that simply piles up standard numbers without these links is treated as incomplete.

Insight 3: The verification and validation section must be traceable back to the underlying records.

Section 6 of Annex II requires the manufacturer to present the verification and validation data covering, as applicable, analytical performance, clinical performance, stability, software verification and sterilisation validation, among other topics. The working method that survives review is to point every conclusion to a specific report number, version and date, creating a three-level index: from the claim in the documentation, to the summary in the report, to the raw record behind it. When an assessor can move from a GSPR row to a validation report to a raw data record without human intervention from the manufacturer, the file demonstrates the traceability that the Regulation expects, and the number of clarification rounds drops visibly.

Insight 4: The way the technical documentation is organised directly affects review efficiency.

Organising the documentation by common device group, as defined in Article 2(8), allows the shared parts of the file, such as the design and manufacturing information, the quality management system evidence and the risk management system, to be submitted once, with only the differences supplemented device by device. This mirrors the logic of Article 48(7), under which conformity assessment by a notified body is performed on a sample of devices within a common device group. Aligning the internal file structure with that sampling logic significantly reduces the number of assessment rounds, because the reviewer can move from the group-level evidence to the model-specific differences without reconstructing the file.

4. Practical recommendations

1. Build the documentation tree around the six sections of Annex II, and assign a named owner and a defined update trigger to each section, so that no part of the file depends on a single person or on an undefined review cycle.
2. Structure the GSPR matrix with six columns: requirement, applicability, justification, method, evidence and conclusion, and record the document number and version of the evidence in every row so that the matrix remains auditable across revisions.
3. Manage the shared documentation and the device-specific documentation of a common device group in separate layers, so that group-level content is updated once and model-level supplements are the only documents that need repeated submission.
4. Establish a change-to-documentation linkage: any change to the design or the intended purpose first triggers a documentation impact assessment under Article 10(8)(a), before the change is implemented in production.
5. Set the retention period and the retrieval mechanism under Article 10(7), and write the availability obligations of the authorised representative located outside the Union into the process, so that the file can be produced on request for at least 10 years.

5. Verification checklist

• □ The technical documentation has been established under the six sections of Annex II and incorporates the content of Annex III
• □ The GSPR matrix covers all entries of Annex I, and non-applicable requirements are supported by written justifications
• □ Verification and validation data are traceable to the underlying reports, by number, version and date
• □ Shared and device-specific documentation within the common device group is managed in separate layers
• □ A change-to-documentation linkage has been established under Article 10(8)(a)
• □ Retention rules are defined: the documentation is kept for at least 10 years after the last device has been placed on the market

GRZAN supports manufacturers entering or operating in the EU in vitro diagnostic market with full technical documentation services under the IVDR: Annex II and Annex III file architecture, GSPR applicability matrices, verification and validation traceability indices, common device group structuring and notified body readiness reviews. Our regulatory team assembles, updates and defends technical documentation through conformity assessment, so that your file stays complete, current and review-ready for at least 10 years under Article 10(7). Contact us at info@grzanglobal.com for a documentation gap assessment.

Legal information verified as of 29 October 2026.