Person Responsible for Regulatory Compliance: The ”Article 15 Man”

Evnia news

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

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