Find a PRRC (Person Responsible for Regulatory Compliance)
Under MDR/IVDR Article 15, manufacturers of medical devices and IVDs must have a Person Responsible for Regulatory Compliance (PRRC) — in-house or outsourced. Search listed regulatory consultants offering PRRC services, or describe your situation and reach several at once.
Who does what — PRRC vs Notified Body vs Authorized Representative
| Role | What they do |
|---|---|
| PRRC | Internal (or outsourced) compliance function inside the manufacturer — regulatory compliance, technical documentation, vigilance |
| Notified Body | Independent third-party conformity assessment body, external to the manufacturer |
| EU Authorized Representative | EU-based legal contact for a non-EU manufacturer, required separately from the PRRC |
Frequently asked questions
- Can I use an outsourced PRRC instead of hiring in-house?
- Yes. MDR/IVDR Article 15 allows the PRRC role to be fulfilled by an external consultant under contract, provided they meet the same qualification requirements (relevant degree plus experience, or several years of hands-on regulatory experience). Many manufacturers, especially smaller ones, use an outsourced PRRC rather than a full-time hire.
- What qualifies someone as a PRRC?
- Either a university degree in a relevant field (law, medicine, pharmacy, engineering or a related discipline) plus at least one year of regulatory or quality-management experience with medical devices, or four years of hands-on experience in those areas without the degree requirement — microenterprises are exempt from having a PRRC at all, but must have one permanently and continuously at their disposal.
- Is a PRRC the same as a Notified Body or Authorized Representative?
- No — three different roles. A Notified Body performs third-party conformity assessment. An Authorized Representative is the EU-based legal contact for a non-EU manufacturer. A PRRC is an internal (or outsourced) compliance function inside the manufacturer’s own organisation, responsible for regulatory compliance, technical documentation and vigilance obligations.
- How does this directory help me find one?
- Search by keyword and country across listed regulatory consultants — many explicitly offer outsourced PRRC services alongside other regulatory work. Contact details are visible directly, or describe your situation and reach several consultants at once.