PRRC or Person Responsible for Regulatory Compliance is a new requirement for MDR and IVDR and is specified in Article 15. Manufacturers and authorized representatives must have at least one designated person with regulatory competence who is responsible for compliance with the regulations.
The tasks include ensuring that the technical documentation and EU declaration of conformity are drawn up and kept up to date, and that PMS, vigilance and reporting obligations are complied with. In addition, the conformity of the products must be checked before they are placed on the market.
Micro- and small-scale manufacturers will be able to subcontract their PRRC functions to third parties that meet the qualifications specified for the manufacturer's PRRC in Article 15. Mediteq has the required expertise and can act as PRRC on behalf of customers. Mediteq can also help organizations define the PRRC role and understand the full length of the requirements and responsibilities involved with the role as well as provide training for individuals that are appointed PRRC by manufacturers or authorized representatives. Contact us for more information.