EU MDR Technical Documentation
The audit-ready technical file kit for Regulation (EU) 2017/745. Cover the full Annex II structure — from Device Description to Declaration of Conformity — with 8 coordinated templates aligned to the latest MDCG guidance and Team-NB position papers.
Technical
EU MDR Documentation Kit
EU MDR Technical Documentation Kit
The complete Annex II technical file in one coordinated set. Eight professionally drafted templates covering Device Description and Specifications, Labelling and Instructions for Use, Design and Manufacturing Information, General Safety and Performance Requirements, Benefit-Risk Analysis and Risk Management, Verification and Validation, Post-Market Surveillance and the Declaration of Conformity. Built for manufacturers preparing a Notified Body submission and consultants supporting them.
What's inside the kit
Eight Word templates covering the full structure of EU MDR Annex II, plus Annex III (Post-Market Surveillance) and Annex IV (Declaration of Conformity). Each template is mapped to the relevant Annex section.
| ID | Document | Purpose |
|---|---|---|
| TD-001-01 | Device Description and Specifications | General description, intended purpose, classification, specifications, components, accessories, variants and previous generations. |
| TD-001-02 | Labelling and Instructions for Use | Device labelling, package labelling, symbols, Instructions for Use content per Annex I §23, language and electronic IFU considerations. |
| TD-001-03 | Design and Manufacturing Information | Design phases, sites of manufacture, supplier and subcontractor controls, sterilisation processes, key design changes traceability. |
| TD-001-04 | General Safety and Performance Requirements | Conformity demonstration to all 159 General Safety and Performance Requirements of Annex I, with applied standards and evidence references. |
| TD-001-05 | Benefit-Risk Analysis and Risk Management | Benefit-risk analysis per Article 61, risk management process and references, risk acceptability and overall residual risk evaluation. |
| TD-001-06 | Product Verification and Validation | Pre-clinical and clinical data, biocompatibility, electrical safety, software verification, packaging validation, shelf life and stability. |
| TD-001-07 | Post-Market Surveillance | PMS Plan, PSUR/PMS Report, PMCF Plan and Evaluation Report, vigilance reportability decisions, FSCA process and trend reporting. |
| TD-001-08 | Declaration of Conformity | EU Declaration of Conformity content per Annex IV, including manufacturer details, Basic UDI-DI, classification, applied harmonised standards. |
Need clinical and risk documentation too?
Combine this kit with the EU MDR Clinical Documentation Kit and the Risk Management Documentation Kit in one premium bundle. The complete pre-market and post-market documentation for an MDR Notified Body submission, with cross-references between all three kits and a single Master Index.
Technical Documentation
Clinical Documentation
Risk Management
Frequently Asked Questions
Is this kit ready to submit to a Notified Body?
The templates provide the complete structure, methodology and required content sections expected by Notified Bodies for an Annex II technical file. You must populate them with your device-specific data, evidence, drawings, validation reports and analyses. They are professional starting points designed to align with NB review expectations — not a substitute for regulatory expertise.
Which MDR risk classes is this kit suitable for?
All eight templates are applicable to every MDR class (I, IIa, IIb, III) and to custom-made devices with minor adaptation. Class III and implantable devices have additional requirements (SSCP per Article 32, Article 61(5) equivalence requirements) that are addressed in the Clinical Documentation Kit, available separately or in the bundle.
How does this kit relate to the Clinical and Risk Management kits?
This kit covers the full Annex II structure at a high level, while the Clinical Documentation Kit and the Risk Management Documentation Kit go in depth on the clinical evaluation, post-market surveillance, hazard analysis and FMEAs that this kit references. For a complete pre-market and post-market documentation set, the MDR Complete Bundle includes all three.
What format are the files in?
All 8 templates are delivered as Microsoft Word .docx files, fully editable. The kit also includes a Master Index spreadsheet (Excel) with cross-references between templates and a README with usage instructions and update frequency guidance.
Are Team-NB position papers integrated?
Yes. The relevant Team-NB position paper requirements are integrated as inline notes throughout the templates: EUDAMED registration prerequisites, Basic UDI-DI assignment, electronic Instructions for Use, SSCP cross-references, PSUR for legacy devices and implant card requirements. Notes are clearly marked so you can review them during compilation.
How do I get updates if MDR or MDCG guidance changes?
You will receive lifetime access to the kit. When MDCG publishes new guidance or significant MDR amendments are released, registered customers receive update notifications by email with revised templates at no additional cost.
Is the kit licensed for use across multiple devices?
The kit is licensed for internal use within your organisation across multiple device families and projects. Internal team members can use and adapt the templates. Redistribution outside your organisation or reselling is not permitted.
Do you offer consulting on top of these templates?
Yes. For complex projects (full technical file drafting, NB audit preparation, gap analyses, design history file consolidation) we offer dedicated consulting services. Contact us through the consulting page.