Person Responsible for Regulatory Compliance (PRRC): ensure full MDR & IVDR compliance without risk
Ensuring compliance under MDR and IVDR is no longer a formal step—it is a structural requirement for accessing and maintaining your position on the EU market. At the centre of this framework is the Person Responsible for Regulatory Compliance, a mandatory role introduced under Article 15 to ensure that device conformity, technical documentation, and post-market obligations are continuously controlled within the organisation.
The PRRC is not just a title. It represents defined accountability across the entire product lifecycle, requiring permanent availability and real oversight of regulatory activities. When implemented correctly, the Person Responsible for Regulatory Compliance becomes the function that connects quality, regulatory strategy, and operations—turning compliance from a risk into a controlled, scalable system.
Integrated Person Responsible for Regulatory Compliance (PRRC) support across your organisation
A Person Responsible for Regulatory Compliance cannot operate in isolation. Under MDR and IVDR, compliance depends on how regulatory affairs, quality systems, and post-market activities function together in practice. This is where most PRRC models fail: the role exists, but the system behind it is not aligned.
Our PRRC service is built as part of a fully integrated regulatory framework. We connect regulatory affairs, medical device vigilance, quality management, and medical expertise into one coordinated system, ensuring that compliance is consistently applied across all functions.
This means your Person Responsible for Regulatory Compliance is not reacting to issues, but actively controlling them through structured processes, clear responsibilities, and continuous oversight. Regulatory requirements are translated into working systems, and post-market obligations are managed proactively.
The result is a compliance model that is inspection-ready and scalable—supporting growth, market expansion, and increasing regulatory complexity without loss of control.