Module 17 2024

27/11/2024

The Role of the RA Professional

Person Responsible for Regulatory Compliance in the MDR(PRRC)

• Responsible for regulatory compliance

• Responsible for ensuring that:

• Device conformity checked

• Technical documentation kept up to date

• Declaration of Conformity drawn up/kept up to date

The Organisation for Professionals in Regulatory Affairs

Lecture 1

5

The Role of the RA Professional

Person Responsible for Regulatory Compliance in the MDR(PRRC)

• Responsible for ensuring that:

• PMS obligations are complied with

• Vigilance Reporting obligations are fulfilled

• Statement of compliance (for clinical investigational devices)

The Organisation for Professionals in Regulatory Affairs

Lecture 1

6

3