The Medical Devices Introductory Course 2020

Annex XI Part B: Product Verification (MDD Annex IV)

• Is batch testing of either the complete batch or a sample of the complete batch • The NB performs the examinations and tests. Upon completion the NB issues a EU Product Verification Certificate relating to the batch • For class III and class IIb devices the NB verifies that the manufactured product conforms to the product type described in the EU Type Examination Certificate • For class IIa the NB verifies that the manufactured product conforms to the product type described in the Technical Documentation - see Annex XI.18 • Rarely used (has to be done for each batch)

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The Organisation for Professionals in Regulatory Affairs

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Conformity Assessment Annexes Comparison MDD vs. MDR

MDD

MDR

ANN II (FULL QMS)

ANN IX CH I (QMS)

ANN II.4 (DESIGN EXAMINATION) ANN III (TYPE EXAMINATION) ANN IV (EC VERIFICATION) ANN V (PRODUCTION QA)

ANN IX CH II (TECHNICAL DOCUMENTATION)

ANN X (TYPE EXAMINATION)

ANN XI PART B (PRODUCT VERIFICATION)

ANN XI PART A (PRODUCTION QA)

ANN VI (PRODUCT QA)

NO LONGER AVAILABLE

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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