Hi Rajeswari,
How about the "performance test reports post accelerated aging study" as one of the objective evidence - indicating a start date and end date of the devices' effective performance? I consider this as solid evidence for the expected device lifetime!
Have you presented any such evidence during your submission? How was the NB's response? Kindly share your experience.
Thank you.
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ASHA JOHNSON
Regulatory Affairs Consultant (Device compliance - EU)
I3CGLOBAL, India
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Original Message:
Sent: 16-Jan-2023 11:58
From: RAJE DEVANATHAN
Subject: Expected device lifetime
HI,
EUMDR - evidence for the expected device lifetime is varies for each device.
"It is a period during which the device is intended to perform its function per the risk and benefit profile of a medical device and maintain its benefits without adding an incremental risk to the patient. This will totally depend on the intended use and indication of use. This depends on difference factors based on the devices inclusive of reliability testing, clinical performance, residual risk, clinical evaluation and post market surveillance, shelflife, material degradation, packaging stability, sterility assurance. Each element has to analyzed in detailed to arrive at the result.
Hope this helps.
Thanks
Kind regards,
Raje
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
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RAJESWARI DEVANATHAN
Senior Manager
Oakville ON
Canada
Original Message:
Sent: 13-Jan-2023 02:43
From: Asha Johnson
Subject: Expected device lifetime
Hello All,
Those who have received EC certification (EU MDR) for your devices, kindly let me know how you have presented the "evidence for the expected device lifetime".
Thank you!
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ASHA JOHNSON
Regulatory Affairs Consultant (Device compliance - EU)
I3CGLOBAL, India
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