The revision 1 of the MDCG 2019-07 Guidance on Article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) on #PRRC has been published in December 2023, bringing substantial enhancements and clarifications.
📚 Reordered document sections to align with the numbering of Article 15 MDR/IVDR paragraphs.
🌟 Expanded references to ‘in vitro diagnostic medical devices’ throughout the document.
🎓 Introduction of new sections for clarity and precision.
💡 Clarifications on qualifications, professional experience, and PRRC location for manufacturers and micro/small manufacturers.
🚀New insights into the roles and responsibilities of the PRRC, including added sections on suffering no disadvantage and obligations of entities assuming manufacturer responsibilities.
🌐 Inclusion of registration of the PRRC in EudraMed.
These revisions aim to provide a more comprehensive understanding of the roles, qualification and responsibilities of the ‘person responsible for regulatory compliance’ within the regulatory landscape, ensuring alignment with the latest MDR/IVDR requirements.
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