EU MDR & IVDR Technical Documentation & GSPR
We build and review Annex II / III technical documentation as one connected regulatory argument. Each major claim is traced to the risk controls, verification/validation evidence, clinical or performance evidence and labeling that support it.
How NKB Reviews the Technical File
We review the technical documentation as one connected regulatory argument rather than isolated folders.
Intended Purpose
Claims
GSPR Mapping
Risk Controls
V&V Evidence
Clinical / Performance
Labeling Alignment
Technical Documentation Scope (Annex II & III)
Device Description & Specification
Including variants, configurations, accessories and Basic UDI-DI identification.
Information Supplied by Manufacturer
Labeling, Instructions for Use (IFU), packaging and multilingual requirements.
Design & Manufacturing Information
Design stages, critical suppliers, manufacturing processes and validation.
Demonstration of Conformity with GSPR
Applicability rationale, harmonised standards & objective evidence mapping.
Benefit-Risk Analysis & Risk Management
ISO 14971 risk management file, hazard identification & risk control verification.
Product Verification & Validation
Biocompatibility, electrical safety, software, bench testing & clinical/performance data.
Post-Market Surveillance Documentation
PMS plan, PMS report / PSUR, PMCF/PMPF plan & vigilance procedures.
GSPR Evidence Mapping with Objective Substantiation
A reference to a harmonised standard is not enough if the underlying evidence does not actually demonstrate the applicable requirement. We challenge both the applicability rationale and the quality of the test reports, validation records, or clinical/performance data cited.
Documentation Review Checklist
- Cross-document terminology consistency
- Risk-benefit alignment with clinical data
- Labeling claims verified against test reports
- Annex III PMS alignment with CER/PER
Audit-Ready Dossiers
Avoid costly Notified Body nonconformities with pre-submission technical documentation audits.
Request File AuditTransform Your Technical File into a Defensible Conformity Package
Our senior specialists review and structure your Annex II & III documentation for seamless Notified Body approval.