How do manufacturers build MDR-compliant technical documentation that passes notified body audits?
Technical documentation per Annex II/III is the central evidence package the notified body audits. Two structures must interlock: the GSPR checklist per Annex I links each of the General Safety and Performance Requirements to a specific piece of evidence - not a generic cross-reference, but the exact document and the relevant section. UDI per Art. 27 and EUDAMED registration per Art. 29 connect the device to the regulatory database infrastructure. The most common notified body finding: GSPR requirements addressed with general references instead of document-specific evidence links.
- MedTech
- IVD
Overview
What does the notified body examine in the technical documentation?
Technical documentation per Annex II/III · UDI per Art. 27 · EUDAMED per Art. 29
Last updated: 2026-06-17
Technical documentation is more than a document folder. It must demonstrate that a product meets all General Safety and Performance Requirements from Annex I - completely, traceably and with ISO 14971 risk management as the connecting thread. Four points where audits regularly get stuck:
- Incomplete GSPR checklist: the notified body expects the specific evidence for each applicable requirement from Annex I, including document title, revision and relevant section. Generic references to the QM system are not sufficient.
- Missing equivalence demonstration or incomplete clinical evidence: where proprietary clinical data is absent and the equivalence route is used, Annex XIV requires access to the technical documentation of the equivalent device. Without that access, the route is blocked.
- UDI implementation left too late: UDI-DI and UDI-PI must appear on the label and packaging, within the device itself (for implantable devices) and in EUDAMED. Retrofitting at the end of the certification process is costly and delays market launch.
- Living documentation vs one-off creation: technical documentation is not a project that ends with CE marking. Change management, PMS findings and re-evaluations per Art. 61 must keep the document status current.
Services
How we support you
Inventory & Gap Analysis
As-is analysis of existing documentation against the requirements of Annex II/III and Annex I, with prioritized gaps and effort estimate per requirements chapter.
GSPR Checklist per Annex I
Structured development of the GSPR traceability matrix: each applicable requirement linked to the evidence document, revision and page reference, non-applicable requirements with documented rationale.
UDI Implementation & EUDAMED
Structuring of UDI-DI and UDI-PI per Art. 27, registration with an accredited issuing entity (GS1, HIBCC or ICCBBA) and complete EUDAMED database entries per Art. 29.
Learn more →Annex II/III Build & Audit Preparation
Creation or revision of technical documentation per Annex II, including SSCP per Annex III for class III and implantable devices, and audit readiness check prior to submission to the notified body.
Learn more →How we work together
What it comes down to
Technical documentation is the foundation of MDR conformity - not because it is the most extensive task, but because it provides the only complete proof that a product meets all General Safety and Performance Requirements from Annex I. Two things determine whether the notified body accepts documentation without additional requests: the quality of GSPR traceability and the consistency between clinical evaluation, risk management and technical specifications.
The GSPR checklist per Annex I is more than a checklist. It is the structure that shows how requirement, evidence and risk assessment relate to each other. Those who fill it in at the end of the project realize too late which evidence is still missing. Those who maintain it as a living document from the start have an answer to every auditor question - with page reference.
Our approach
Our approach
Step
Result
Inventory
Complete inventory of existing technical documents, revision levels and open gaps per Annex II chapter.
GSPR Gap Analysis
Prioritized list of missing evidence per Annex I requirement, with effort estimate and sequencing recommendation.
Document structure per Annex II
Agreed technical documentation outline covering all mandatory chapters per Annex II, embedded in the existing QM system.
GSPR checklist & traceability
Complete linkage of all applicable GSPR requirements to specific evidence documents - audit-proof and revision-controlled.
UDI & EUDAMED
Registered UDI-DI and UDI-PI, complete EUDAMED entries, label and packaging compliant per Art. 27.
Audit readiness check
Documentation mock-audit-ready: completeness verified, cross-references validated, SSCP (where required) approved.
Common pitfalls
Where projects commonly fail
GSPR requirements are addressed with generic document references instead of document-specific evidence links.
The notified body demands precision: title, revision and section of the evidence document - blanket references to the QM manual or ISO 13485 certificate are not evidence.
Technical documentation is treated as a one-off project.
PMS findings, vigilance cases and design changes must feed back into the documentation; without structured change management, a discrepancy arises between the declared and actual product status.
UDI implementation is deferred to the end of the project.
Registration with an accredited issuing entity, label updates and EUDAMED entries have lead times; starting too late risks delaying market launch despite completed certification.
For class III and implantable devices, the SSCP per Annex III is missing.
The Summary of Safety and Clinical Performance is mandatory, must be validated by the notified body and published in EUDAMED - it is not an optional accompanying document.
Non-applicable GSPR requirements are deleted without justification.
Each requirement must either be addressed with evidence or classified as not applicable with a documented rationale. Missing justifications trigger additional requests.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR) - Art. 10, 27, 29, 61, Annex I, II, III
- ISO 13485:2016 - Quality management systems for medical devices
- ISO 14971:2019 - Application of risk management to medical devices
- MDCG 2019-16 Rev.1 - Guidance on Unique Device Identification (UDI)
- MDCG 2020-6 - Guidance on sufficient clinical evidence for legacy devices
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR)
- MDR Annex I (General Safety and Performance Requirements, GSPR)
- MDR Annex II (Technical Documentation)
- MDR Annex III (Summary of Safety and Clinical Performance)
- MDR Art. 10 (General obligations of manufacturers)
- MDR Art. 27 (UDI system)
- MDR Art. 29 (Registration of devices in EUDAMED)
- ISO 13485:2016 (QM System)
- ISO 14971 (Risk Management)
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