The Medical Devices Introductory Course 2020

• Is product testing or inspection by a NB • The M submits the Technical Documentation plus a representative sample (“Type”) to the NB • The NB examines the documentation and inspects and/or tests the sample. Upon completion the NB issues an EU Type Examination Certificate • The M must also comply with Annex XIA (Production Quality Assurance) or Annex XIB (Product Verification) • Used for class III and IIb devices • Rarely used (expensive) Annex X: Type Examination (MDD Annex III)

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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• Is QMS for Production (not Design) • Must be assessed by a NB. Upon completion the NB issues an EU Quality Assurance Certificate • Used for class III or IIb in combination with Annex X (Type Examination). • Used for class IIa, IS, IMF and IRSI in combination with Annexes II and III (Technical Documentation) – see Annex XI.10 Annex XI, Part A: Production Quality Assurance (MDD Annex V)

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

20