PRRC (Person Responsible for Regulatory Compliance)
We help you set up PRRC coverage and PRRC-facing processes under MDR/IVDR — including documentation readiness and compliance procedures.
What PRRC means in practice
Under EU medical device regulations, many organizations must have a Person Responsible for Regulatory Compliance (PRRC). Beyond the title, it requires clear responsibilities, documentation access, and internal procedures so the role can be performed effectively.
Our PRRC support
- Role scoping: PRRC tasks mapped to your product lifecycle
- Qualification fit check (documented evidence pack)
- Procedure set-up: document control, vigilance triggers, escalation paths
- Interfaces: manufacturer ↔ EU AR ↔ importer/distributor (as applicable)
- Ongoing support: change management and post‑market workflows
Common deliverables
- PRRC role description and RACI matrix
- PRRC checklist for technical documentation release
- Post‑market / vigilance workflow overview
- Compliance communication plan
Note: Exact PRRC requirements depend on your business model and product classification. We start every project with a scope confirmation.
