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The convergence of the pharmaceutical and medical devices industries
Find out more about the different categories of combination products within the EU along with the regulatory pathways designed to ensure they are safe and perform as intended.
Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15
With the MDR and IVDR, European regulators aim to ensure companies have a regulatory expert – a Person Responsible for Regulatory Compliance (PRRC) – at their disposal, to ensure that the company is meeting certain specific EU requirements.