PRRC for medical device manufacturers
We help you establish PRRC coverage and PRRC-facing procedures under MDR/IVDR — so the role is auditable and practical, not only “on paper”.
Why PRRC matters (from archived materials)
Archived project materials state it plainly: manufacturers must have a Person Responsible for Regulatory Compliance (PRRC) as one of the requirements under MDR and IVDR. The intent is to ensure companies have a qualified regulatory expert at their disposal.
The same archived text also notes practical complexities such as multiple legal manufacturers (each should appoint its PRRC) and the need to confirm PRRC coverage in the EU-side setup.
What PRRC is responsible for (MDR focus)
The archived PRRC page summarizes MDR Article 15(3) responsibilities as ensuring that:
- Device conformity is appropriately checked according to the QMS before release
- Technical documentation and the EU Declaration of Conformity are drawn up and kept up to date
- Post‑market surveillance obligations are complied with (e.g., MDR Article 10(10))
- Vigilance reporting obligations are fulfilled (Articles 87–91: serious incidents, FSCAs, trend reporting)
- For investigational devices, the statement in Annex XV (Chapter II, Section 4.1) is issued
The archived text also highlights a key operational point: the PRRC role should be included in the quality management system and is subject to scrutiny during audits. It further notes that the PRRC is not required to personally perform every task, but to ensure the tasks are performed under their responsibility.
Typical pain points we fix
- PRRC is nominated but responsibilities are not documented
- No clear release process for technical documentation and declarations
- Weak post‑market / vigilance triggers and escalation
- Interfaces with EU AR / importer / distributor are not defined
Our deliverables
- PRRC role description and responsibility matrix
- Document control and release checklist
- Change control and post‑market workflow overview
- Evidence pack for PRRC qualification fit (as applicable)
How we start
- Confirm MDR vs IVDR scope and your market model
- Collect current procedures and sample documentation
- Define gaps + implement a minimal effective PRRC system
Note: This page provides general information. Exact PRRC obligations depend on your organization, device portfolio and applicable regulation (MDR vs IVDR). We confirm scope before starting.
