Article 15 of the EU MDR and IVDR require that european manufacturers and manufacturers located outside the EEA, and their EU authorised representatives shall appoint a PRRC.

The document clarifies that due to transitional provisions, appointing a Person Responsible for Regulatory Compliance (PRRC) isn't mandatory for "legacy" medical devices under the EU MDR and IVDR. While a partial PRRC role might be possible, its implementation can be complex. Consequently, manufacturers often choose to apply full PRRC oversight even to these "legacy" devices to simplify Quality Management Systems.