Advena offers the service of designated Person Responsible for Regulatory Compliance (PRRC) on behalf of a Manufacturer but what is a PRRC, why is it needed and why and how can this role be outsourced?
What and who can be a PRRC?
Individual/s identified by a Manufacturer to be responsible for regulatory compliance who meet the minimum qualification (degree or equivalent in law, medicine, pharmacy, engineering or relevant science) and/or professional experience (medical device regulatory or quality) detailed in Article 15 of EU MDR (EU/2017/745) and EU IVDR (EU/2017/746).
Reasons for outsourcing PRRC?
1. Manufacturer does not have anyone in their organisation that meets the minimum qualification and/or experience.
and/or
2. Manufacturer size (people and annual turnover) meets the criteria to be able to outsource by having ‘someone permanently and continuously at their disposal’.
Advantages of outsourcing the PRRC role
- Reduced cost – manufacturer does not need to employ someone into Quality and/or Regulatory role.
- Reduced internal burden – manufacturer can focus on driving their business and assisting customers.
- Compliance achieved – contracted PRRC meet experience and qualification requirements.
- Impartiality – external review and maintenance of technical documentation.
How can Advena UK help?
We are a well-respected, established, Medical Device Regulatory Consultancy with over 35 years of experience across our expert team of Consultants.
