Class I Self-Declaration

Overview

For standard Class I devices, the manufacturer performs a self-declaration under MedDO Annex IV — no notified body is involved. Despite the absence of NB review, the full technical documentation requirements apply and the manufacturer bears complete responsibility for compliance.

Class I Sub-Classes

Sub-class	Description	NB Required?
Class I (standard)	Non-sterile, non-measuring, non-reusable surgical	No
Class Im	Measuring function	Yes (metrology aspects only)
Class Is	Supplied sterile	Yes (sterility aspects only)
Class Ir	Reusable surgical instruments	Yes (reprocessing aspects only)

Annex IV Procedure (Standard Class I)

1. Compile full Annex II and Annex III technical documentation
2. Conduct ISO 14971 risk management
3. Complete GSPR compliance matrix
4. Issue and sign the Declaration of Conformity
5. Notify or register device in DAPI within 30 days of first market placement

Common Misconception

Class I devices require the same depth of technical documentation as higher-class devices. The only difference is that the NB does not review it. Swissmedic may request technical documentation during market surveillance at any time.

Official Sources

• MedDO Annex IV (SR 812.213)

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.