Person Responsible for Regulatory Compliance Training | PRRC Training

PRRC Training Under EU MDR and IVDR for Your Organisation

Preparing your Person Responsible for Regulatory Compliance? The PRRC role under EU MDR and IVDR carries significant responsibility, and ensuring your designated person — and their supporting team — has the right knowledge is essential for maintaining compliance. We deliver targeted PRRC training programmes covering the regulatory competence requirements of Article 15, practical compliance responsibilities, and how to structure PRRC oversight within your quality management system.

Article 15 Competence Requirements and PRRC Responsibilities

Our PRRC programmes go beyond the basics of the role definition. We cover the qualifications and experience requirements under the MDR and IVDR, how to demonstrate and document regulatory competence, the PRRC’s responsibilities in relation to technical documentation and declarations of conformity, vigilance and post-market surveillance obligations, and how the PRRC role interacts with your QMS and organisational structure. We can also address scenarios where PRRC responsibilities are outsourced or shared across multiple sites. For a broader understanding of the regulatory landscape, our medical device regulatory training and IVD training programmes complement PRRC training well, particularly for team members supporting the PRRC function.

PRRC Compliance Training for Single Sites or Multi-Site Organisations

Whether you need training for a single PRRC, a team of regulatory professionals supporting the PRRC function, or a wider organisational awareness session on what the PRRC role means for your business, we can tailor the programme accordingly. Explore our team training solutions or get in touch to discuss PRRC training for your organisation.

Free Medical Device Resources

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