Understanding the PRRC Role Under MDR: A Comprehensive Guide and How AF Pharma Can Support You
The European Medical Device Regulation (MDR 2017/745)Â has introduced significant changes in how medical devices are regulated in the EU, including the mandatory appointment of a Person Responsible for Regulatory Compliance (PRRC). This requirement applies to manufacturers and certain economic operators, ensuring that every entity involved in placing medical devices on the market has qualified oversight.
In this blog, we’ll explore the PRRC role in depth, its regulatory basis in MDR, and how AF Pharma can support your compliance needs by providing experienced PRRC services.
The PRRC MDR Requirement: MDR Article 15
The requirement for a PRRC is outlined in Article 15 of MDR, which mandates that manufacturers, authorized representatives (ARs), and in some cases, importers must designate a PRRC. This individual is responsible for ensuring that the organization complies with MDR’s stringent requirements.
Key Responsibilities of the PRRC
According to Article 15, the PRRC's duties include:
Conformity of Devices: Ensuring that the device conforms to the MDR before being placed on the market.
Technical Documentation: Reviewing and maintaining the technical documentation, including periodic updates.
Post-Market Surveillance: Overseeing compliance with the post-market surveillance (PMS) system under Article 83 of MDR.
Incident Reporting: Ensuring timely reporting of serious incidents and field safety corrective actions (FSCA) per Article 87 and 88 of MDR.
Declaration of Conformity: Verifying that declarations of conformity are correctly issued and maintained.
Who Needs a PRRC MDR?
1. Manufacturers
All medical device manufacturers, regardless of size, must appoint a PRRC MDR. Micro and small enterprises are not exempt from this requirement.
2. Authorized Representatives (ARs)
If the manufacturer is located outside the EU, the Authorized Representative must also designate a PRRC.
3. Importers (Under Specific Circumstances)
Importers who act as "virtual manufacturers" or assume responsibilities equivalent to a manufacturer may also need a PRRC MDR.
Qualifications of a PRRC MDR
The MDR requires the PRRC MDR to possess specific qualifications, which include:
Formal Qualifications: A degree in law, medicine, pharmacy, engineering, or another relevant field.
Regulatory Experience: At least one year of professional experience in regulatory affairs or quality management systems related to medical devices.
Alternatively, individuals without a formal degree may qualify if they have four years of proven professional experience in regulatory affairs or quality management for medical devices.
Challenges in Meeting the PRRC Requirement
1. Internal Expertise
Many organizations, especially small or medium enterprises, lack the internal resources to meet the qualifications required for a PRRC MDR.
2. Dual PRRC Roles
For non-EU manufacturers, both the manufacturer and their EU Authorized Representative need PRRCs, adding complexity and cost.
3. Liability and Risk
The PRRC bears significant legal and regulatory responsibility. Organizations must ensure their PRRC is fully qualified and adequately trained to mitigate compliance risks.
How AF Pharma Supports PRRC Compliance
At AF Pharma, we provide comprehensive PRRC services, tailored to meet the specific needs of manufacturers, authorized representatives, and importers. Here’s how we can help:
1. Acting as Your External PRRC MDR
If your organization lacks the in-house expertise, our team can serve as your designated PRRC, fulfilling all regulatory requirements under MDR Article 15.
2. Expertise Across Multiple Regions
With deep knowledge of EU regulations, we ensure your devices meet compliance standards. Whether you're transitioning from MDD to MDR or introducing new devices, we’ve got you covered.
3. Technical Documentation and PMS Support
Our experts assist with compiling, reviewing, and updating technical documentation and implementing robust PMS systems, ensuring your ongoing compliance.
4. Incident Reporting and FSCA Management
We manage incident reporting and field safety corrective actions, ensuring timely submissions to Competent Authorities.
5. Training and Guidance
For companies wishing to appoint an internal PRRC, we offer tailored training to ensure your candidate meets the qualifications and understands their responsibilities.
Why Choose AF Pharma for PRRC Services?
AF Pharma is a trusted regulatory partner with extensive experience in medical device compliance. Based in Spain, we specialize in EU MDR compliance, offering tailored solutions that streamline your regulatory processes.
Benefits of Partnering with AF Pharma:
Access to qualified regulatory experts.
Comprehensive support for PRRC responsibilities.
Expertise in managing MDR requirements across a wide range of device classes.
Peace of mind knowing your compliance is in capable hands.
Secure Compliance and Focus on Innovation
The PRRC role is a cornerstone of MDR compliance, ensuring that your organization maintains the highest standards of safety and quality. By partnering with AF Pharma, you can meet the PRRC requirement confidently and focus on what matters most—delivering innovative, life-changing medical devices to the market.
For more information on our PRRC services or to schedule a consultation, visit AF Pharma Services today. Let us help you navigate MDR compliance with ease!
Comments