Checklist for the evaluation of the PRRC

CHF49.00

This checklist serves to assess and verify the qualification as of a person, willing to act as PRRC (Person Responsible for Regulatory Compliance) under the Medical Device Regulation (MDR) 2017/745, article 15. Here, you can find the checklist, which is available as:

  • Word file format,
  • with form fields,
  • corresponds to the requirements of the MDR 2017/745, article 15,
  • corresponds to the guielines and understanding of the Notfied Bodies in the EU,

as a download in English.

Category:

Description

The Medical Device Regulation (MDR) 2017/745 in its article 5 demands every manufacturer and authorized representative to have a Person Responsible for Regulatory Compliance (PRRC) at its disposal. The MDR has a clear specification on the selection requirements of a person acting as PRRC. This checklist serves to assess and verify the qualification as a PRRC.

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