Module 17 2024

27/11/2024

The Role of the RA Professional

The UK Responsible Person

Responsibilities include:

•

• Declaration of Conformity, technical file, conformity assessment

• Provide device samples to MHRA on request

• Cooperate with MHRA on CAPAs to eliminate/mitigate risks

• Immediately inform manufacturer about complaints/suspected incidents

• Terminate contract in case of non compliance by the manufacture

The Organisation for Professionals in Regulatory Affairs

Lecture 1

11

The Role of the RA Professional

Proposed Future Requirement – A qualified Person

• Responsibilities would include supporting the manufacturers UK compliance

• Minimum qualifications/experience

• Within the manufacturers organisation (except SMEs)

• UKRP to have a qualified person

The Organisation for Professionals in Regulatory Affairs

Lecture 1

12

6