Margarita Rozhdestvenskaya

EU Authorized Representative (EU-REP) for Medical Devices

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Legal Requirements and Practical Implementation under MDR/IVDR EU Authorized Representatives are not only subject to the legal requirements of the MDR and IVDR. They are also liable for violations of medical device law. This expert article provides practical answers to all regulatory questions relating to the EU-REP with specific recommendations for action from the leading consulting firm for…

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MDR / IVDR – “Person Responsible for Regulatory Compliance” (PRRC)

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Both the MDR and the IVDR require a “person responsible for regulatory compliance” (PRRC). Some people also call them the “article 15 person” (after the corresponding articles in the two EU regulations) or the “qualified person”. The terms “person responsible for compliance with regulatory requirements” (abbreviated to “person responsible”) and “qualified or competent person” are used in German. The “person…

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