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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 the NB is designated and actively notified under EU MDR/IVDR for your specific device class and application type via the NANDO database; verify that the NB's scope explicitly covers your device technology (e.g., software-based, implantable, in vitro diagnostic)
  • Ask for realistic timelines and confirm current NB capacity — notified body backlogs have been significant since the MDR transition; plan 18–24+ months for Class III devices requiring design examination, particularly if multi-site QMS audits are needed
  • Confirm availability of audit team in your working language

Language Considerations for Audit Team ​ Confirm with the NB that the audit team speaks your working language (English is standard, but German, French, or Italian may be preferred). If technical documentation is in a language other than English, the NB may require English summaries of critical sections. Budget additional time if simultaneous translation is required. Miscommunication during audits due to language barriers can result in audit delays or findings — ensure clarity upfront.

Official Sources​

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