Hello Christopher,
The United States and European regulatory systems are different and they look at clinical data from investigations/trials differently. If a clinical investigation was performed 10 years ago, you will need to determine if as part of the clinical evaluation process this is sufficient clinical evidence. As Anne said, you will need to review the adequacy of all available clinical data to determine whether sufficient clinical evidence supports the safety and performance of the device for CE Marking in the European Union.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Apr-2022 12:31
From: Anne LeBlanc
Subject: Clinical Investigation
Hi Christopher
The basic EU MDR requirement is that there should be sufficient clinical evidence. Your clinical evaluation plan and clinical evaluation report can refer to the 10 years ago investigation and to a review of published literature and to a decade of postmarket surveillance data. You will have to review the adequacy of all the available information and determine if more is needed.
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Anne LeBlanc
United States
Original Message:
Sent: 22-Apr-2022 01:32
From: Christopher Chin
Subject: Clinical Investigation
If a manufacturer had obtained FDA 510k clearance on class II medical device 10 years ago, is it mandatory to perform another clinical investigation to comply with EU MDR requirements?
Christopher Chin