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Questions regarding Technical files 13485/MDR

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Guest user Created:   Aug 29, 2022 Last commented:   Aug 29, 2022

Questions regarding Technical files 13485/MDR

1: Do we need a Technical File for outsourced products that are manufactured elsewhere?

2: Do we need a Technical File for products that we relabel?

3: Do we need a Technical File for products that we do not adapt or manufacture ourselves but that we buy and resell (as part of one of our products)?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Aug 29, 2022
1: Do we need a Technical File for outsourced products that are manufactured elsewhere?
You need to have a technical file for products that you are placing on the market. If products that are manufactured elsewhere are part of your final device, yes you need to have all necessary documentation from that outsourced product in your technical file.

2: Do we need a Technical File for products that we relabel?

Again, the question is who places the product on the market. If by putting the label you state that you are a manufacturer, in that case, you need to have the whole technical file. If with putting the label you state that you are a distributor, in that case, you do not have proper Technical documentation, rather medical device file according to the ISO 13485, requirement 4.2.3 which will then contain the EC certificate, instructions for use, information on installation/service and the like, depending on the type of product.

3: Do we need a Technical File for products that we do not adapt or manufacture ourselves but that we buy and resell (as part of one of our products)?

I believe that I have answered this in the previous two answers. If something else needs to be clarified, feel free to contact us.

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Aug 29, 2022

Aug 29, 2022

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