Essentials of European Medical Device Regulatory Affairs - October 2019

MDR Annexes

Annex IX  Annex X Annex XI  Annex XII 

Conformity Assessment  – Quality Management System

Conformity Assessment  – Type Examination

Conformity Assessment  – Product Conformity Verification

Certificates issued by a Notified Body

Annex XIII  Custom‐made devices  Annex XIV  Clinical evaluation and 

Post market clinical follow up (PMCF)

Annex XV  Clinical investigations Annex XVI  List products without a medical purpose  Annex XVII  Correlation table with the MDD

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The Transition Period and “The Grace Period”

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