What Conformity Assessment Bodies Do
Overview
Conformity Assessment Bodies (CABs) — notified bodies (NBs) — are independent third-party organisations designated by EU member states to perform conformity assessment for medical devices requiring third-party review. For Switzerland, these are EU-designated NBs under EU MDR or IVDR.
Core NB Functions
QMS Audit (Annex IX Chapter I) The NB audits the manufacturer's QMS against ISO 13485 and MedDO/MDR requirements. Issues a QMS certificate valid for up to 5 years. Annual surveillance audits are conducted. Full reassessment every 5 years.
Technical Documentation Assessment (Annex IX Chapter II — Class III / IVD List A) Full review of technical documentation for each device or device group: GSPR compliance matrix; clinical evaluation; risk management file; design documentation. Issues a design examination certificate for Class III devices.
Type Examination (Annex X) NB examines a representative sample (design documentation + physical testing). Issues an EU Type Examination Certificate.
SSCP Validation For Class III and implantable devices: NB validates the Summary of Safety and Clinical Performance as part of conformity assessment. See SSCP.
Unannounced Audits EU MDR/IVDR requires at least one unannounced audit per manufacturer per 5-year certificate period. The manufacturer cannot refuse entry. Unannounced audits focus on production processes and CAPA implementation.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.