Qualifications of EU-rep from May 26th
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Yes, you are correct. You must have an EU rep according to the requirements from the IVDR when you will be ready for the certification with IVDR. For more details please see Article 110 from the IVDR 2017/746 Transitional provisions. There is stated that the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, and registration of economic operators, and devices shall apply and replace the corresponding requirements in that Directive 98/79/EC.
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Apr 04, 2022

