ISO 13485 and IVD
I have a question about IVD
if I have an in vitro diagnostic device intended for professional use not listed in annex II of IVDD 98/79/EC
and I want to sell the product in other countries instead of EU but these countries require that the product to be CE mark (customer in XYZ for example)
can I issue the self-declaration and put CE on the product without authorized representative?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, you can make a self-declaration and put a CE mark on the device. Your Declaration will be check by National regulations in the country where you will register the product.
Authorized representative is necessary for Manufacturers that are outside of Europe and want to sell their products on the EU market. So, if you want to sell your product in XYZ, you do not need an authorized representative.
For more information please read the following articles:
How to use ISO 13485 to comply with In Vitro Diagnostic medical devices (IVD) requirements in UK https://advisera.com/13485academy/blog/2017/10/26/how-to-use-iso-13485-to-comply-with-in-vitro-diagnostic-medical-devices-ivd-requirements-in-uk/
How to use ISO 13485 to get your devices approved for CE Marking https://advisera.com/13485academy/blog/2017/10/12/how-to-use-iso-13485-to-get-your-devices-approved-for-ce-marking/
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Mar 03, 2020