Manufacturers may be able to outsource the PRRC role depending on the size and revenue of the company. Per MDR and IVDR article 15(2), micro and small manufacturers “shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.” Footnote 3 of the MDCG PRRC guidance (MDCG 2019-7) further clarifies that ‘micro and small manufacturers’ means entities with fewer than 50 employees and/or where the annual revenue does not exceed €10 million.  In these cases, the PRRC role can be outsourced. If the PRRC role is outsourced, the manufacturer must demonstrate how the PRRC is permanently and continuously at the disposal of the company.  Further, the PRRC’s qualifications must be documented. Generally, this is done with a contract.