EU Authorised Representative Services for Medical Device & IVD Manufacturers
Selling medical devices or IVDs in Europe? If your company is based outside the EU, appointing an EU Authorised Representative (EC Rep) is a legal requirement under EU MDR 2017/745 and IVDR 2017/746. Patient Guard provides expert EU Authorised Representative services, EUDAMED support, regulatory guidance, and ongoing compliance management to help manufacturers access and maintain the European market with confidence.
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