Enough for PSUR to cover product family? (Procedure packs, not the legal manufacturer)

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Jonathanlai928

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#1
#1
I understand PSUR requirements are for each product but MDR also mentions if applicable, each 'product family'.

We don't manufacture devices, only package CE marked products for procedure packs. Effectively we're middle men. Is it right for the PSUR to just cover product classes instead of every individual product as we technically have over 1000, the workload will be unthinkable.
 
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Junn1992

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#2
#2
I recommend starting with MDCG 2019-13 part 3 which defines category of devices and generice device group as defined by the 4th level of the EMDN code. Note that these definitions are not the same as 'medical device family' under ISO 13485. But logically, devices which have the same exact EMDN code are obviously part of the same 'family' under ISO 13485. The problem arises when grouping devices which have the same 4th level of EMDN, but have different intended use. I would say that grouping based on intended use would be the best option, as such grouping will cover both PMS, PMCFs, and can be shown on the same DoC.
 
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