Understanding the PRRC IVDR
The In Vitro Diagnostic Regulation (IVDR 2017/746) has revolutionized the regulatory landscape for in vitro diagnostic (IVD) devices in the European Union. A key element of this regulation is the mandatory appointment of a Person Responsible for Regulatory Compliance (PRRC IVDR) to ensure the safety, quality, and compliance of IVD products. In this blog, we delve into the PRRC’s responsibilities under IVDR, its legal basis, and how AF Pharma can support your organization by providing PRRC services tailored to meet IVDR requirements.
PRRC Requirement: IVDR Article 15
Similar to the MDR, Article 15 of IVDR requires manufacturers and certain economic operators to appoint a PRRC. This role is mandatory in ensuring that all IVD devices placed on the EU market comply with the regulation.
Key Responsibilities of the PRRC IVDR
According to Article 15, the PRRC IVDR need to follow the tasks mentioned below:
Conformity of Devices: Verifying that devices meet IVDR requirements before market placement.
Technical Documentation: Reviewing and maintaining up-to-date technical documentation.
Post-Market Surveillance (PMS): Overseeing PMS systems as outlined in Article 78 of IVDR.
Vigilance Activities: Ensuring timely reporting of serious incidents and field safety corrective actions (FSCAs) per Article 82 and 83.
Declaration of Conformity: Ensuring that declarations of conformity are correctly issued for all devices.
Who Needs a PRRC IVDR?
1. Manufacturers
All IVD manufacturers, regardless of size, must appoint a PRRC to oversee compliance with IVDR.
2. Authorized Representatives (ARs)
Non-EU manufacturers must designate a PRRC through their Authorized Representative to ensure IVDR compliance.
3. Importers (Under Specific Circumstances)
Importers acting as virtual manufacturers or taking on manufacturer responsibilities may also need to designate a PRRC IVDR.
Qualifications of a PRRC
To be eligible as a PRRC under IVDR, an individual must possess certain qualifications and experience, specially it is needed:
Formal Qualifications: A degree in medicine, pharmacy, engineering, or another relevant scientific discipline.
Professional Experience:
At least one year of experience in regulatory affairs or quality management systems related to IVDs.
Alternatively, four years of proven professional experience in these areas for individuals without a formal degree.
Challenges in Meeting PRRC Requirements
1. Limited Internal Resources
Many small and medium-sized enterprises (SMEs) lack qualified personnel to fulfill the PRRC role, particularly in specialized fields like IVDs. Here is where we can help you, outsourcing your PRRC to us!
2. Dual PRRC Requirement
For non-EU manufacturers, both the manufacturer and their EU Authorized Representative must designate a PRRC, increasing complexity. AF Pharma already have a PRRC and we have at your service more PRRCs!
3. Vigilance and PMS Oversight
Effective implementation of post-market surveillance and incident reporting systems requires expertise and significant resources.
4. Evolving Regulations
The IVDR introduces stricter requirements, and organizations must stay updated to avoid compliance gaps.
How AF Pharma Supports PRRC Compliance for IVDR
At AF Pharma, we offer comprehensive PRRC services to help IVD manufacturers, authorized representatives, and importers navigate the complexities of IVDR compliance.
1. Acting as Your External PRRC
If your organization lacks the in-house expertise, our qualified regulatory professionals can serve as your designated PRRC, fulfilling all responsibilities under IVDR Article 15.
2. Technical Documentation Expertise
We assist in compiling, reviewing, and maintaining technical files that comply with IVDR standards, ensuring your documentation is always audit-ready.
3. Post-Market Surveillance (PMS) Systems
Our team helps implement and manage robust PMS systems, including periodic safety update reports (PSURs), as required under IVDR.
4. Vigilance and Incident Reporting
We oversee the reporting of serious incidents and FSCAs, ensuring timely communication with EU Competent Authorities.
5. Training and Support
For organizations seeking to designate an internal PRRC, we provide targeted training to ensure your team understands and fulfills IVDR requirements.
Why AF Pharma?
AF Pharma has a proven track record in regulatory compliance for medical devices and in vitro diagnostics. Based in Spain, we specialize in helping companies meet the stringent requirements of MDR and IVDR, offering tailored solutions for businesses of all sizes.
Benefits of Choosing AF Pharma:
Access to highly qualified regulatory professionals.
Comprehensive support for PRRC responsibilities, PMS, and vigilance.
Expertise across multiple regions, ensuring seamless compliance.
Tailored services for all classes of IVD devices.
Take the Stress Out of IVDR Compliance
The PRRC role is critical to ensuring compliance with IVDR and maintaining trust in your IVD devices. With AF Pharma’s experienced regulatory experts, you can confidently meet PRRC requirements while focusing on innovation and market growth.
Let AF Pharma guide your path to IVDR compliance. Visit AF Pharma Services to learn more about our PRRC services and how we can support your success in the EU market!
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