PRRC role & requirements
A practical overview of PRRC expectations under MDR/IVDR and what companies should implement to make the role effective and auditable.
What PRRC is
PRRC (Person Responsible for Regulatory Compliance) is a key compliance function required by EU medical device regulations (MDR/IVDR) for many organizations. The role must be backed by access to documentation, defined responsibilities and real procedures — not only a name on paper.
Who can be a PRRC (qualification concept)
In general, the regulations describe PRRC expertise as being demonstrated by either:
- Relevant formal qualification (e.g., law, medicine, pharmacy, engineering, or another relevant scientific discipline) plus at least 1 year of professional experience in regulatory affairs or QMS relating to medical devices, or
- 4 years of professional experience in regulatory affairs or QMS relating to medical devices.
In practice, companies should be able to document professional experience (e.g., contracts, org charts, training evidence, internal records such as document releases).
There is also MDCG guidance (MDCG 2019‑7) that clarifies interpretation points — for example, how to treat qualifications acquired outside the EU.
How companies usually implement PRRC
- Assign a named PRRC (internal or external model depending on eligibility)
- Document PRRC responsibilities (RACI matrix, role description)
- Create a release gate for technical documentation and declarations
- Define post‑market and vigilance workflows (signals → assessment → escalation)
- Set up change control (design changes, labeling changes, supplier changes)
What we can help with
- Gap assessment and minimal effective PRRC system setup
- Procedure templates and checklists (tailored to your product class)
- Interfaces with EU AR / importer / distributor
- Evidence pack support for PRRC appointment (qualification documentation)
Note: This is general information. Specific obligations depend on your organization, device portfolio and applicable regulation (MDR vs IVDR).
