Dear Colleagues,
my understaning is that for a small manufacturer (devices up to 10) the maintenance of the activities related to PMS part of the QMS (monthly status report, training, regular literature search, internal correspondence, SOP update) needs about 0,5 FTE. I would calculate 4-5 hours for the management of one incoming incident report. All this would depend on how detailed the activities need to be according to the NBs & NCAs.
regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
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Original Message:
Sent: 10-Feb-2022 04:17
From: Adam Gregory
Subject: EU MDR Postmarket Benchmarking
Hi Rene,
I currently manage a team which runs through 18 yearly PSURs, 5 PSURs due every two years and 2 PMS Reports (non-EU) due every 2 years. We currently have one full time dedicated PMS expert that manages all of those on an ongoing basis. What I will say is we have found a huge benefit in streamlining the underlying processes to make the data collection significantly more efficient which has saved a huge amount of time to allow more focus on the generation of the report itself I would say without that it would require more than 1 FTE to manage.
Thanks!
Adam
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Adam Gregory
Regulatory Affairs Manager
Winsford
United Kingdom
Original Message:
Sent: 09-Feb-2022 09:21
From: Rene' Hardee
Subject: EU MDR Postmarket Benchmarking
Hi RAPS Community,
Can anyone point me to some benchmarking data ragarding the cost of maintaining EU MDR Postmarket requirements? Or is anyone willing to share how many headcounts you have managing your EU MDR postmarket program? (If you could also state how many products/report you need to generate, that would be extremely helpful!)
Thanks all!
-Rene'
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Rene' Hardee
Regulatory Affairs Manager
Rockledge, FL
United States
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