Let's say that for a medical device that I want to put in the EU market I will buy the parts A and B outside the EU market, and attach them together to make my final medical device (basically the parts would be purchased according to specifications and only a simple assembly would be done in a EU country).
Would this be considered manufacturing a medical device, considering I'd be purchasing parts A and B already finished and only putting them together? (they dont' work independently)
What would the design and development requirements look like in said product, provided the original design for the product would not be mine? Could the company producing parts A and B be classified as a supplier (they manufacture these parts for other companies in other non-eu countries)?
I was expecting that I'd have to specify design and development for the final product, including specifications for the parts A and B to which the supplier would have to comply, but don't know how it would be possible to comply with design and development for each part (since I don't have access to that data).
Thank you
Would this be considered manufacturing a medical device, considering I'd be purchasing parts A and B already finished and only putting them together? (they dont' work independently)
What would the design and development requirements look like in said product, provided the original design for the product would not be mine? Could the company producing parts A and B be classified as a supplier (they manufacture these parts for other companies in other non-eu countries)?
I was expecting that I'd have to specify design and development for the final product, including specifications for the parts A and B to which the supplier would have to comply, but don't know how it would be possible to comply with design and development for each part (since I don't have access to that data).
Thank you