One important new requirement in both MDR and IVDR is to have an assigned and dedicated Person Responsible for Regulatory Compliance (PRRC). The PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies. This is conducted by ensuring that the technical documentation and declaration of conformity is drawn up and kept up to date, fulfilling the obligations related to post market surveillance as well as reporting and investigating vigilance issues. It is also required that the PRRC controls the conformity of devices before they are released.
All manufacturer irrespective of classification, must have this person identified to fulfill the requirements and placing devices on the market under MDR and IVDR.
QAdvis can help you with understanding the requirements in your company as well as taking the role as PRRC in micro and small companies.
We can support you with defining the role as well as training and understanding of the full range of responsibilities. Learn more about our half day course here.