IVD Technical File Preparation under IVDR Annex II & III
We prepare complete, Notified Body-ready technical files for in vitro diagnostics: device description, GSPR checklist, analytical and clinical performance, stability, risk management and post-market surveillance, so your IVDR review runs without avoidable questions.
What is an IVD technical file?
An IVD technical file is the evidence that your in vitro diagnostic meets the General Safety and Performance Requirements of EU IVDR 2017/746. Its content is set out in Annex II for pre-market documentation and Annex III for post-market surveillance.
Compared with a medical device file, an IVD file places much more weight on analytical performance, stability and metrological traceability. For Class B, C and D devices, the Notified Body reviews it before issuing a CE certificate.
What IVDR Annex II requires
Six sections, each complete and consistent with the others. Section 6 is where IVD files differ most from medical device files.
| Section | What it contains | What reviewers check |
|---|---|---|
| 1. Device description | Intended purpose, analyte, specimen type, intended user, variants, accessories and Basic UDI-DI | A clear, consistent intended purpose |
| 2. Information supplied | Labels and instructions for use, including self-testing and near-patient testing information | Claims match the performance data |
| 3. Design & manufacturing | Design stages, manufacturing processes, sites and critical suppliers | Control of processes and subcontractors |
| 4. GSPR | Checklist of Annex I requirements, standards and common specifications applied, with evidence references | Every applicable requirement is justified |
| 5. Benefit-risk & risk management | Risk management file under ISO 14971 and benefit-risk analysis | Risks of false results addressed and linked to labelling |
| 6. Verification & validation | Analytical performance, clinical performance and PER, stability (shelf life, in-use, transport), software validation and sterility where relevant | Data that supports every claim in the IFU |
Post-market surveillance documentation for IVDs
What you must collect and report once the IVD is on the market. Requirements depend on class.
| Document | Applies to | How often |
|---|---|---|
| PMS plan | All classes | Kept current for the life of the device |
| PMS report | Class A and B | Updated when necessary |
| PSUR | Class C and D | At least once a year |
| PMPF plan & report | All classes, unless justified | Feeds the PER and PSUR |
| SSP | Class C and D | Updated with each PSUR where needed |
How we prepare your IVD technical file
A structured process that turns scattered data into a file your Notified Body can review quickly.
- 1
Gap analysis
Week 1–2We review existing documents, study reports and any IVDD file against Annex II and III and list what is missing.
- 2
File structure & plan
Annex II & IIIWe set up the file index and a plan for missing studies, including analytical and stability testing.
- 3
Device, labelling & GSPR
Sections 1–4We write the device description, review labels and IFU, document design and manufacturing and build the GSPR checklist.
- 4
Analytical performance & stability
Section 6.1 · 6.3We compile study protocols and reports, metrological traceability and shelf-life data.
- 5
Performance evaluation & risk
Annex XIII · ISO 14971We prepare the PEP, PER, SSP where needed, and the risk management file.
- 6
Quality review
Before submissionAn independent reviewer checks the file for consistency and completeness against Notified Body expectations.
- 7
Submission & query support
Through to certificateWe support the Notified Body review and answer technical documentation questions until closure.
Common IVD technical file gaps
Our IVD technical file services
IVD technical file FAQs
Do Class A IVDs need a technical file?
Yes. Every IVD, whatever its class, needs full Annex II and III documentation. For non-sterile Class A devices it is not reviewed by a Notified Body, but it must be ready for competent authorities on request.
How long must IVD technical documentation be kept?
Under IVDR Article 10, for at least 10 years after the last device covered by the EU Declaration of Conformity has been placed on the market.
What analytical performance data does the file need?
Typically accuracy (trueness and precision), analytical sensitivity and specificity, limits of detection and quantitation, measuring range, cut-off, interference and cross-reactivity, metrological traceability and specimen stability, depending on the device.
What is a Summary of Safety and Performance (SSP)?
The SSP is a public summary required for Class C and D IVDs under IVDR Article 29. It is validated by the Notified Body and published in EUDAMED, and must stay consistent with your technical file and performance evaluation.
Can you upgrade our IVDD technical file to IVDR?
Yes. We run a gap analysis against Annex II and III, then update the GSPR checklist, analytical and clinical performance data, performance evaluation, risk file, labels and PMS documentation.
How long does it take to prepare an IVD technical file?
It depends on class and how much analytical and clinical performance data already exists. With test data in place, a complete file typically takes 8 to 16 weeks.
Want your IVD technical file checked before submission?
Send us your device details using the form below and we'll tell you what's missing at no cost.
