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Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies

#1
Hi All,

We are developing an IVD Device and are still within the Design and Development phase. We have manufactured validation batches that need to be run to check if the expected performance was achieved. The testing of the validation batches will be performed onsite in the UK and by our subsidiary in the US. The validation devices are labelled as "for performance evaluation only".

The definition of the device for performance evaluation in the article 1 of the Directive is following:
(e) ‘device for performance evaluation’ means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises;

The question is following: do we need to prepare the statement as per Annex VIII of the IVD Directive? Can we claim that since the US part is our subsidiary the testing is going to be performed in our own premises? Since we are still in the D&D phase - does the Annex VIII apply at all?

Thanks!
 
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chris1price

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#2
If you are shipping to the USA, then the EU IVD Directive does not apply. However, FDA does have its own labelling.
  • - A product in the laboratory research phase, not represented as an IVD, that is prominently labeled: "For Research Use Only. Not for use in diagnostic procedures;"
  • - A product that is being shipped or delivered for product testing prior to full commercial marketing that is prominently labeled: "For Investigational Use Only. The performance characteristics of this product have not been established.
See
https://www.fda.gov/downloads/Medic...onandGuidance/GuidanceDocuments/UCM376118.pdf
In Vitro Diagnostic Device Labeling Requirements
 
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