MDR Technical Documentation for CE Marking
We prepare complete, audit-ready technical documentation under MDR Annex II and III, from device description and GSPR checklist to risk management, verification, clinical evaluation and post-market surveillance, so your Notified Body review runs without avoidable questions.
What is MDR technical documentation?
MDR technical documentation, also called the technical file, is the evidence that your device meets the General Safety and Performance Requirements of EU MDR 2017/745. Its structure is set out in Annex II for pre-market documentation and Annex III for post-market surveillance.
Every device needs one, whatever its class. For Class IIa, IIb and III devices, the Notified Body reviews it before issuing a CE certificate, and it must be kept up to date for the life of the device.
What MDR Annex II requires
Annex II sets out six sections. Each must be complete, consistent with the others and easy for a reviewer to follow.
| Section | What it contains | What reviewers check |
|---|---|---|
| 1. Device description | Intended purpose, variants, accessories, Basic UDI-DI, specifications, previous generations and similar devices | A clear, consistent intended purpose |
| 2. Information supplied | Labels and instructions for use in the languages of the markets | Claims match the clinical and risk evidence |
| 3. Design & manufacturing | Design stages, manufacturing processes, sites and critical suppliers | Control of processes and subcontractors |
| 4. GSPR | Checklist of Annex I requirements, standards applied and evidence references | Every applicable requirement is justified |
| 5. Benefit-risk & risk management | Risk management file under ISO 14971 and benefit-risk analysis | Risks reduced as far as possible and linked to labelling |
| 6. Verification & validation | Pre-clinical tests (biocompatibility, electrical safety, software, sterility, stability, usability) and clinical evaluation | Test reports and a CER that support every claim |
Post-market surveillance documentation
Annex III covers what you must collect and report once the device 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 I | Updated when necessary |
| PSUR | Class IIa | At least every two years |
| PSUR | Class IIb and III | At least once a year |
| PMCF plan & report | All classes, unless justified | Feeds the CER and PSUR |
How we prepare your technical documentation
A structured process that turns scattered data into a file your Notified Body can review quickly.
- 1
Gap analysis
Week 1–2We review your existing documents, test reports and any MDD 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 each missing piece, including testing that still needs to be done.
- 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
Risk & verification
ISO 14971 · ISO 10993 · IEC 62366-1We prepare the risk management file and compile verification and validation evidence, coordinating tests with associated labs.
- 5
Clinical evaluation & PMS
Annex XIV · Annex IIIWe write the CER, PMCF plan, PMS plan and PSUR or PMS report.
- 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 your Notified Body submission and answer technical documentation questions until closure.
Common technical documentation gaps
Our technical documentation services
MDR technical documentation FAQs
What is MDR technical documentation?
It is the set of documents, often called the technical file, that proves your device meets EU MDR 2017/745. Its content is set out in Annex II (technical documentation) and Annex III (post-market surveillance documentation).
Do Class I devices need technical documentation?
Yes. Every class needs full Annex II and III documentation. For Class I devices it is not reviewed by a Notified Body (unless sterile, measuring or reusable surgical), but it must be ready for competent authorities on request.
How long must technical documentation be kept?
Under MDR Article 10(8), at least 10 years after the last device covered by the EU Declaration of Conformity is placed on the market, and at least 15 years for implantable devices.
What is the GSPR checklist?
It is a table showing how your device meets each General Safety and Performance Requirement in MDR Annex I, with the standards applied and references to the evidence in your file. Notified Bodies review it closely.
Can you upgrade our MDD technical file to MDR?
Yes. We run a gap analysis of your MDD file against Annex II and III, then update the GSPR checklist, risk file, clinical evaluation, labels and PMS documentation to meet MDR.
How long does it take to prepare MDR technical documentation?
It depends on device class and how much test and clinical data already exists. With test reports in place, a complete file typically takes 8 to 16 weeks.
Want your 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.
