Manufacturers
Overview
Under MedDO Art. 4, a manufacturer is any person who makes a device available under their own name or trademark, whether or not they physically produce it. Manufacturers bear the full range of regulatory obligations under MedDO.
Core Obligations
Quality Management System — Class IIa+ and implantable Class I devices require a QMS conforming to ISO 13485. The QMS must cover design controls, risk management, supplier controls, production, CAPA, and post-market surveillance.
Technical Documentation — All manufacturers must compile and maintain the full Annex II (general) and Annex III (PMS) documentation demonstrating GSPR compliance.
Conformity Assessment — Complete the appropriate conformity assessment (Annex IV self-declaration for Class I; NB routes for Class IIa+). Issue a Declaration of Conformity before market placement.
Swissmedic Registration — Register or notify the device in DAPI before or within 30 days of market placement (depending on class).
Post-Market — Active PMS, vigilance reporting to Swissmedic via eVigilance, FSCA implementation and notification.
Non-Swiss Manufacturers
Must appoint a CH REP before placing devices on the Swiss market. See CH REP.
Official Sources
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.