EU MDR Technical Documentation Kit
€429.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Regulation (EU) 2017/745 · Annex II · Annex IV
EU MDR Technical Documentation Kit
Eight templates covering the full Annex II technical file a Notified Body expects for a Class I, IIa, IIb or III device, with Team-NB position paper requirements built in as inline notes.
Annex II is eight sections, not eight documents
Annex II lists sections, not deliverables, and a technical file assembled section by section from scratch usually misses the connective detail a Notified Body actually checks: the Basic UDI-DI carried consistently across the file, the EUDAMED references, whether electronic instructions for use are permitted for this device, and how the SSCP and legacy-device PSUR obligations apply.
Those are exactly the points Team-NB position papers exist to clarify, and they are easy to miss if the eight sections are written as isolated documents instead of one file that carries the same identifiers throughout.
None of this is difficult. It is the consequence of treating Annex II as a list of headings rather than as one coordinated file.
- 8 Word documents
- 1 Excel index
- Single ZIP
- Instant download
- Fully editable
- Team-NB notes included
Scope
What the kit covers
Every section of Annex II, plus the Declaration of Conformity of Annex IV, with Team-NB position paper requirements integrated as inline notes throughout.
01
Device description and design
Device Description and Specifications (Annex II Section 1), Labelling and Instructions for Use (Section 2), and Design and Manufacturing Information (Section 3).
02
GSPR and benefit-risk
General Safety and Performance Requirements (Section 4 and Annex I), and Benefit-Risk Analysis and Risk Management (Section 5 and Article 61).
03
Verification and post-market
Product Verification and Validation (Section 6.1), Post-Market Surveillance (Section 6.1(c) and Annex III), and the Declaration of Conformity (Annex IV).
Contents
What is in the ZIP
Audience
Who the kit is for
- Regulatory affairs managers assembling an Annex II technical file
- Manufacturers preparing a first Notified Body submission
- Consultants who need a file structured the way a reviewer reads it
- PRRC and quality managers reviewing a file before it is submitted
The kit assumes you know your device’s classification and intended use, and that risk and clinical evidence exist or are being produced alongside it. It does not teach MDR Annex II: it gives you the file structure, with the Team-NB clarifications already built in.
What is included
What you get when you buy
- 8 Microsoft Word documents, fully editable
- 1 Microsoft Excel master index
- Team-NB position paper requirements as inline notes: EUDAMED, Basic UDI-DI, electronic IFU, SSCP cross-references, legacy-device PSUR, implant card
- Delivered as a single ZIP, instant download after purchase
Questions
Before you buy
Does this include the risk management file?
Section 5 references the benefit-risk conclusion and risk management summary; the underlying risk file itself is the Risk Management Documentation Kit, sold separately.
Does this include clinical evaluation?
No. Clinical evaluation, PMCF and PSUR documents are covered by the EU MDR Clinical Documentation Kit, sold separately or in a bundle.
What are the Team-NB notes?
Inline clarifications, at the point in each document where they apply, covering EUDAMED registration, Basic UDI-DI consistency, when electronic instructions for use are permitted, SSCP cross-references, legacy-device PSUR obligations and the implant card.
Does this work for a Class I device?
Yes. Annex II applies across all classes; sections that do not apply to a given class or device type are marked as such rather than removed, so the file structure stays consistent.
What software do I need?
Microsoft Word and Excel, or a compatible alternative that opens .docx and .xlsx files without reflowing tables.
Is this a one-off purchase?
Yes. The licence is for single-organisation use and the files are yours to keep, with no recurring cost.
Can I use this for an IVDR device?
No. IVDR technical documentation follows Annex II and III of the IVDR, not the MDR. Use the equivalent IVDR technical documentation kit.
Can my company buy several licences?
Yes. Contact us before purchasing and we will arrange it under one invoice.
Need clinical and risk documentation too?
The Complete Bundle adds both files at a lower combined price.
Combine this kit with the EU MDR Clinical Documentation Kit and the Risk Management Documentation Kit in the MDR Complete Bundle and save 15%: €999 against €1,177 buying separately.
EU MDR Technical Documentation Kit
Eight Annex II documents, one ZIP, Team-NB notes built in.
€429.00
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