IVDR technical documentation & PMS/PMPF.
Documentation is where most IVDR submissions succeed or stall — and the most common failure is a technical file disconnected from the actual evidence. FirsTeckBio prepares the IVDR Annex II & III technical documentation, the Annex XIII performance evaluation document chain and the post-market files. Because the same team also runs the studies, every document connects to real study design, clinical evidence and notified-body review logic.
Technical documentation (IVDR Annex II & III)
The submission set notified bodies read first, structured the way they expect it.
- STED / technical file: Summary technical documentation, device description, intended purpose, variants and accessories.
- GSPR checklist: General Safety and Performance Requirements (Annex I) checklist with evidence mapping to each requirement.
- Risk management file: ISO 14971 risk management plan, FMEA, risk-benefit analysis and residual-risk justification.
- SOTA — state of the art: State-of-the-art analysis benchmarking the device against current diagnostic practice.
- SSP — Summary of Safety & Performance: Summary of Safety and Performance for Class C and Class D devices, as required by IVDR Article 29.
- IFU & labelling: Instructions for use and labelling review against IVDR Annex I Chapter III and eIFU requirements.
Performance evaluation documents
The Annex XIII document chain — written to connect with the underlying study data, not float free of it.
- PEP — Performance Evaluation Plan: The plan that defines how scientific validity, analytical and clinical performance will be demonstrated.
- SVR — Scientific Validity Report: Documenting the validated association between analyte and clinical condition.
- APR — Analytical Performance Report: Consolidated analytical performance evidence with traceability to source data.
- CPR — Clinical Performance Report: Clinical performance results, statistics and discussion of the intended-purpose claim.
- PER — Performance Evaluation Report: The top-level Annex XIII deliverable integrating SVR, APR and CPR.
- CPSP & CPSR: Clinical Performance Study Protocol and Clinical Performance Study Report for dedicated Annex XIII Section 2 studies.
Post-market surveillance & vigilance
IVDR makes PMS a continuous obligation — proactive monitoring, not just reaction. We can carry the ongoing burden for you.
- PMS plan & system: Post-market surveillance plan and procedures aligned with your QMS (IVDR Article 79).
- PMPF plan & report: Post-Market Performance Follow-up plans and reports, with literature and registry scanning (Annex XIII Part B).
- PSUR & trend reporting: Periodic Safety Update Reports for Class C/D, trend reporting and vigilance case handling.
Take the documentation burden off your team
Tell us which documents you need written or reviewed. Our medical writers prepare submission-ready files — and connect them to the evidence behind them.
See a sample STED outline