PRRC

The Person Responsible for Regulatory Compliance (PRRC) is a mandatory role under EU MDR Article 15 that requires manufacturers to designate at least one qualified individual who is permanently and continuously responsible for ensuring compliance with the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).

EU MDR Article 15 requirements:

The PRRC must:
- Be permanently and continuously at the disposal of the manufacturer
- Possess the requisite expertise in the field of medical devices
- Be responsible for regulatory compliance on behalf of the manufacturer
- Ensure the manufacturer is in compliance with EU MDR obligations

Qualification requirements:

The PRRC must hold one of the following qualifications:
1. Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline, AND
2. At least one year of professional experience in regulatory affairs or quality management systems relating to medical devices or IVDs

OR

1. At least four years of professional experience in regulatory affairs or quality management systems relating to medical devices or IVDs

Key responsibilities:

The PRRC ensures:
- Conformity of devices to applicable regulations
- Preparation and maintenance of technical documentation
- Post-market surveillance system implementation
- Vigilance reporting (serious incidents and field safety corrective actions)
- Registration in EUDAMED database
- CE marking compliance
- Declaration of Conformity preparation
- Quality management system compliance
- Clinical evaluation and post-market clinical follow-up activities

PRRC vs Qualified Person under previous directives:

Under the previous Medical Device Directive (MDD 93/42/EEC), a "Qualified Person" was required but with less stringent qualification requirements. The EU MDR PRRC role has:
- More clearly defined qualification criteria
- Expanded responsibilities including EUDAMED and post-market activities
- Greater accountability for overall regulatory compliance
- Requirement for permanent and continuous availability

Can the PRRC be external?

Yes, particularly for small and medium enterprises (SMEs):
- The PRRC may be an employee of the manufacturer or contracted externally
- External PRRCs must be permanently and continuously available
- Many manufacturers use regulatory consulting firms to provide PRRC services
- The PRRC can serve multiple manufacturers but must dedicate sufficient time to each
- The manufacturer remains ultimately responsible for regulatory compliance

Documentation requirements:

Manufacturers must document:
- PRRC designation and appointment
- PRRC qualifications (degrees, certificates, professional experience)
- PRRC contact information
- PRRC responsibilities and authority within the organization
- Evidence of permanent and continuous availability

Relationship to other roles:

The PRRC may also serve as:
- Quality management representative (if qualified)
- EU Authorized Representative (if based in EU)
- Notified body liaison
- Clinical evaluation coordinator

However, clear separation of duties and conflict of interest avoidance is important.

PRRC for manufacturers outside the EU:

For manufacturers established outside the EU:
- Must appoint an EU Authorized Representative (EU AR)
- The EU AR typically designates a PRRC within their organization
- The PRRC acts on behalf of the manufacturer for EU regulatory compliance
- The manufacturer retains ultimate responsibility for compliance

Compliance considerations:

• Failure to designate a qualified PRRC is a serious MDR violation
• PRRC qualifications are verified during notified body audits
• Competent authorities may request evidence of PRRC appointment and qualifications
• PRRC turnover requires timely replacement to maintain continuous compliance
• PRRC must have access to all necessary information and authority to fulfill obligations

The PRRC role is central to EU MDR compliance, ensuring manufacturers have dedicated, qualified oversight of regulatory requirements throughout the device lifecycle.