Module 16 2022

9/2/2022

Conclusions • The emphasis and scope of PMCF has changed under the MDR • More effort required • Inter-related processes • Claims for legacy devices all need to be supported • Utilising the Article 120 grace period • Pragmatic PMCF approaches to gather relevant data • Once certified under MDR likely that most devices will be

Conclusions

undertaking PMCF as per Annex XIV • Expectations of Notified Bodies variable • Interpretation of MDCG guidance • CEN ISO/TR 20416:2020

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