The technical documentation is the evidence file that proves a device is safe and performs as intended. It is what a notified body assesses, what an auditor inspects, and what must be defended for the life of the product.
Under the MDR, technical documentation is compiled to Annex II (technical documentation) and Annex III (documentation on post-market surveillance). Both must be kept current and available to the notified body and competent authorities.
What Annex II must contain
- Device description and specification, including variants and accessories.
- Information supplied by the manufacturer — labels and instructions for use.
- Design and manufacturing information.
- The General Safety and Performance Requirements checklist.
- Benefit-risk analysis and risk management.
- Product verification and validation, including the clinical evaluation report.
The GSPR: the essential requirements
The General Safety and Performance Requirements sit in Annex I and are the requirements every device must meet — 23 requirements across three chapters: general requirements including risk management and benefit-risk, design and manufacture, and the information supplied with the device.
Conformity is demonstrated through a GSPR checklist that maps each applicable requirement to the standards applied and the evidence that shows it is met — or a justification where a requirement does not apply. A thin or generic GSPR checklist is one of the most common reasons a technical file is sent back.
Risk management runs throughout
Benefit-risk determination and risk management are not one-off exercises. Residual risks must be reduced as far as possible without harming the benefit-risk ratio, and must remain acceptable when weighed against the device’s benefits — continuously, across the lifecycle.
How PQRA helps
PQRA builds and reviews MDR technical documentation, GSPR checklists and risk-management files — structured to pass notified body assessment.
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