Today we summarize the profile of the ”Art. 15 Man”!Today we summarize the profile of the ”Art. 15 Man”!
EU-MDR 2017/745 mandates that MedTech companies have a regulatory expert, who will be ensuring that the company conforms with the certain requirements. Each Authorized Representative must also gave at least one PRRC.
Evnia’s tips:
- You can have more than one PRRC with different roles and responsibilities that must be defined in written
- Name and contact details of the PRRC will be disclosed in the EUDAMED database
- The PRRC does NOT replace the #AuthorizedRepresentative. You need both if you located outside of the EU!✔ The role is also mandatory in the IVDR context
Read more Profile & Requirements for PRRC
