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QMS Requirements Under MedDO/IVDO

Overview​

A quality management system (QMS) is required for manufacturers of Class IIa, IIb, III, and implantable Class I devices under MedDO. The QMS must cover all activities relevant to the quality and safety of the device, from design through distribution and post-market surveillance.

When a QMS is Required​

Device ClassQMS Mandatory?NB QMS Audit?
Class I (standard, non-implantable)Strongly recommended, not formally required for conformity assessmentNo
Class Im, Is, IrRecommendedNo (NB involvement limited to specific aspect)
Class IIaYes — full ISO 13485 QMSYes (Annex IX Chapter I)
Class IIbYes — full ISO 13485 QMSYes (Annex IX Chapter I)
Class IIIYes — full ISO 13485 QMS + design controlsYes (Annex IX Chapters I and II)
IVD List AYesYes
IVD List B / Self-testYesYes (Chapter I)
IVD GeneralRecommendedNo

QMS Scope Requirements​

The QMS scope must cover all processes that affect device quality:

  • Design and development controls (required for Class II/III) — see Design Controls & CAPA
  • Risk management — ISO 14971 process must be integrated with the QMS
  • Purchasing and supplier controls — see Supplier Controls
  • Production and process controls — manufacturing process validation, environment controls
  • Inspection and testing — incoming inspection, in-process testing, final release
  • Nonconforming product controls — process for identifying and managing nonconforming devices
  • CAPA — corrective and preventive action system
  • Complaint handling — receiving, evaluating, and responding to customer complaints
  • Post-market surveillance — PMS data collection and review integrated with the QMS
  • Management review — periodic senior management review of QMS performance

MedDO-Specific Elements Beyond Standard ISO 13485​

MedDO/MDR conformity assessment requires the QMS to address certain elements that go beyond standard ISO 13485 certification scope:

  • GSPR compliance management — processes ensuring all devices placed on the market continue to comply with applicable GSPRs
  • Unique Device Identification (UDI) — processes for UDI assignment, labelling, and DAPI registration
  • Post-market surveillance integration — active PMS system generating data that feeds back into risk management and GSPR compliance
  • PSUR preparation — processes for preparing periodic safety update reports on schedule
  • SSCP maintenance — for Class III/implantable devices: processes for updating and validating the SSCP

Official Sources​

Disclaimer

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