Do I need to get registered or have German entity to sell IVD products in Germany?

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chris1price

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Under the current IVD Directive, you do not have to register in Germany or have a German representative. Depending on where your company is based, you may need an authorised representative in EU.

When the IVD Regulation comes into force in 2022, the requirements for Importers and Distributor comes into effect. Given the additional requirements, I would start working on the new regulation now, if you haven't already done so.
 
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