Module 16 2022

9/2/2022

Source: https://eu-udi.zendesk.com/hc/en-150/articles/360019389377-What-about-Legacy-devices-

MDR Legacy Device - Key Impacts

 The transition period covers requirements for Legacy Device and Old Devices

 New and different MDR requirements apply for Legacy Devices

 Implement all applicable QMS regulatory Requirements for Legacy Devices as set forth in MDCG

 Anticipate MDD Certificate Expiration prior having a new MDR Certification issued by NB

 Anticipate long or very long lead times for MDR Certification with NB

 Consider Contingency Stock for continued EU Distribution

 Be patient and alert for new MDCG publications

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Summary and Learning Outcome

 Transitional Provisions are challenging for Legacy Devices.  Carefully consider proposed design changes for Legacy Devices  Significantly increased PMS Data Collection, Analysis and Reporting Requirements  Uncertainties on NB MDR Certification Timelines and Certification issues  Find a committed MDR Notified Body and carefully plan for contingencies

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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