EU MDR Technical Documentation Kit

EU MDR Technical Documentation Kit

What it is: the complete Annex II technical file for Regulation (EU) 2017/745 in one coordinated set. Eight professionally drafted Word templates covering the full technical documentation expected by Notified Bodies for a Class I, IIa, IIb or III medical device submission.

What is included

• Device Description and Specifications — Annex II Section 1
• Labelling and Instructions for Use — Annex II Section 2
• Design and Manufacturing Information — Annex II Section 3
• General Safety and Performance Requirements — Annex II Section 4 + Annex I
• Benefit-Risk Analysis and Risk Management — Annex II Section 5 + Article 61
• Product Verification and Validation — Annex II Section 6.1
• Post-Market Surveillance — Annex II Section 6.1(c) + Annex III
• Declaration of Conformity — Annex IV
• Master Index spreadsheet + README with usage instructions

Format

8 Microsoft Word documents (fully editable) + 1 Excel Master Index. Team-NB position paper requirements integrated as inline notes throughout (EUDAMED, Basic UDI-DI, electronic Instructions for Use, SSCP cross-references, PSUR for legacy devices, implant card). Delivered as a single ZIP. Instant download after purchase.

Need clinical and risk documentation too?

Combine this kit with the EU MDR Clinical Documentation Kit and the Risk Management Documentation Kit in the MDR Complete Bundle and save 15%: EUR 999 vs EUR 1,177 buying separately.