Class IIa, IIb, III — Notified Body Routes
Annex IX — QMS-Based Route (Most Common)
Chapter I — QMS Assessment: NB audits the manufacturer's QMS against ISO 13485 and MedDO requirements. Issues QMS certificate. Conducts periodic surveillance audits (typically annual). Unannounced audits required at least once every 5 years.
Chapter II — Technical Documentation Assessment (Class III and IVD List A): In addition to QMS audit, NB reviews complete technical documentation for each device or device group — including clinical evidence, GSPR compliance, risk management, and design documentation. For Class III devices: a design examination procedure is required.
Annex X — Type Examination
NB performs type examination of a representative sample. Issues EU Type Examination Certificate. Used in combination with Annex XI (production conformity verification) as follow-up.
Annex XI — Production Conformity Verification
Two options: Chapter I (NB QMS audit of production) or Chapter II (NB testing of finished devices). Used as follow-up to Annex X.
NB Selection Tips
- Confirm NB is designated under EU MDR/IVDR for your device class and type via NANDO
- Ask for realistic timelines — NB capacity has been constrained since MDR transition; plan 12–18+ months for Class III
- Confirm availability of audit team in your working language
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.