PRRC Services for Medical Devices & IVDs (EU MDR & IVDR Compliance)
Our PRRC (Person Responsible for Regulatory Compliance) services support medical device and IVD manufacturers in meeting the regulatory requirements of EU MDR (EU 2017/745) and IVDR (EU 2017/746). Patient Guard provides experienced regulatory professionals to help ensure your organisation maintains compliant regulatory oversight and market readiness.
PRRC Services for Medical Devices & IVDs
Under Article 15 of EU MDR and IVDR, manufacturers must have at least one Person Responsible for Regulatory Compliance (PRRC) permanently and continuously at their disposal.
The PRRC is responsible for overseeing regulatory compliance activities, including technical documentation, conformity assessment procedures, post-market surveillance, vigilance reporting, and regulatory obligations.
Failure to appoint a compliant PRRC may result in regulatory non-conformities, delays in certification, and restrictions on market access.
Patient Guard provides outsourced PRRC services tailored to medical device and IVD manufacturers of all sizes, supporting both start-ups and established global organisations.
Our experienced regulatory professionals ensure your quality management system, technical documentation, and regulatory processes align with EU MDR and IVDR expectations.
We ensure our PRRCs are permanently and continuously at your disposal, as required by the regulation” would be a massive trust signal for an auditor
Why Choose Patient Guard for PRRC Services?
Certified QMS Integration
Our PRRC oversight is delivered entirely within our own BSI-certified ISO 13485 Quality Management System, providing the highest standard of compliance management and rigorous legal oversight.
Permanent & Continuous Availability
We ensure our regulatory specialists are permanently and continuously at your disposal, providing a massive, audit-ready trust signal that directly satisfies Notified Body and competent authority expectations.
Flexible Outsourced Support
Tailored specifically for start-ups, SMEs, and global manufacturers, our outsourced PRRC services provide legal Article 15 coverage with transparent pricing and absolutely no hidden costs.
What Our PRRC Service Includes
Technical Documentation Oversight
We systematically review your technical files and performance files to verify that device batch releases meet the highest standard of conformity before product distribution.
Declaration of Conformity Verification
Our designated PRRC monitors, signs, and continuously manages your Declarations of Conformity, confirming full regulatory adherence under Article 15 mandates.
PMS & Vigilance Monitoring
We provide legal oversight for all post-market surveillance plans, trend assessments, and time-critical vigilance reporting to secure ongoing compliance.
QMS Compliance Reviews
We actively monitor quality system procedures, ensuring your design controls, technical updates, and regulatory processes match EU MDR/IVDR requirements.
Audit & Inspection Readiness
We defend your compliance frameworks during Notified Body interventions, providing expert support to ensure your organization passes lifecycle audits with ease.
Who Requires PRRC Services?
- Medical device manufacturers under EU MDR
- IVD manufacturers under IVDR
- Start-ups without internal regulatory expertise
- Non-EU manufacturers requiring regulatory oversight
- Organisations undergoing Notified Body review
PRRC Requirements Under EU MDR & IVDR
Under Article 15 of EU MDR and IVDR, manufacturers must ensure the PRRC is responsible for:
- Conformity of devices before release
- Technical documentation and EU Declarations of Conformity
- Post-Market Surveillance compliance
- Vigilance reporting obligations
- Statement reporting for investigational and performance study devices
A compliant PRRC function is essential for maintaining CE marking and regulatory compliance.
Our Process
Step 1 – Regulatory Assessment & Appointment
We assess your organisation, devices, and regulatory obligations to determine PRRC requirements and establish support
Step 2 – Documentation & Compliance Oversight
We review technical documentation, quality systems, PMS, and vigilance processes to ensure compliance alignment
Step 3 – Ongoing PRRC Support & Regulatory Guidance
We provide continuous PRRC oversight, regulatory support, and audit readiness assistance throughout the device lifecycle
Industries We Support
We support PRRC services across:
- Medical device manufacturers
- IVD manufacturers
- Digital health and SaMD companies
- Biotechnology and diagnostics companies
- Start-ups and global healthcare organisations
Cost of Service
PRRC Services for IVDR and EU MDR Compliance
From pm
Ensure compliance with EU MDR and IVDR article 15 Pricing starts from £150 per month.
Features
- Outsourced PRRC support aligned with Article 15 of EU MDR and IVDR requirements
- Technical documentation, Declaration of Conformity, and QMS compliance oversight
- PMS, vigilance, and regulatory reporting support throughout the device lifecycle
- Ongoing regulatory guidance and audit readiness support for CE marking compliance
Time Lines
Week 1 – Regulatory Assessment & PRRC Setup
Assess your organisation, device portfolio, and regulatory obligations to establish PRRC requirements and onboarding
Weeks 2–3 – Documentation & Compliance Review
Review technical documentation, quality systems, PMS, and vigilance processes to ensure MDR/IVDR compliance alignment
Ongoing – Continuous PRRC Oversight & Support
Provide ongoing regulatory oversight, audit readiness support, and lifecycle compliance guidance under EU MDR and IVDR
Frequently Asked Questions (FAQs)
What is a PRRC?
A PRRC (Person Responsible for Regulatory Compliance) is the individual responsible for ensuring compliance with EU MDR or IVDR requirements under Article 15.
Is a PRRC mandatory?
Yes, manufacturers under EU MDR and IVDR must have at least one PRRC permanently and continuously available.
Can PRRC services be outsourced?
Yes, SMEs and manufacturers can outsource PRRC services where permitted under EU MDR and IVDR.
What qualifications are required for a PRRC?
The PRRC must possess appropriate regulatory qualifications or professional experience as defined in Article 15.
Can Patient Guard act as our outsourced PRRC?
Yes, Patient Guard provides outsourced PRRC services for both medical device and IVD manufacturers.
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