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
45
The Transition Period and “The Grace Period”
46
Made with FlippingBook - Online magazine maker