Best Practice Guidance for Medical Device Technical Documentation (EU 2017/745)

This position paper provides best practices for submitting technical documentation under Annex II and III of the EU Medical Device Regulation (EU) 2017/745. Key updates include:

Date: 14-Apr-2025

Updates: Rewritten sections on Clinical and PMS, common pitfalls, and clarifications in wording.

Key Aspects Covered:

Scope: Guidance for technical documentation submissions.

General Considerations: Common causes of submission delays and how to avoid them.

Device Description: Consistency in product name, intended purpose, and use across documents.

Manufacturer Info: Declaration of conformity, labeling, IFU, implant card, and surgical brochures.

Design & Manufacturing Info: Details on sites, subcontractors, and compliance with safety requirements.

Safety & Performance: Risk assessment, validation, cybersecurity, EMC, and product verification.

Clinical Evaluation & PMS: Documentation of clinical evaluations and post-market data.

Region: European Union

Source: https://www.team-nb.org/wp-content/uploads/2025/04/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V3-20250409.pdf