PRRC Services
Placing a medical device on the European market under the EU MDR 2017/745 or IVDR 2017/746 comes with strict regulatory obligations. Having a Person Responsible for Regulatory Compliance (PRRC) isn’t just a legal requirement—it’s a strategic advantage.
At Sobel, we offer a full suite of PRRC services in Europe, including expert-led training. Our programs are designed to equip professionals with the knowledge and skills to meet EU regulatory expectations with confidence, turning compliance into a competitive edge.
How We Support Your Regulatory Compliance Strategy
Our services are designed to provide both operational PRRC support and internal team training, helping you build long-term regulatory strength.
Qualified PRRC for Europe: We offer access to experienced PRRC professionals who help with technical documentation, conformity assessments, and CE marking procedures are in full compliance with EU requirements.
Comprehensive Training Programs: Our sessions cover the full scope of the EU MDR PRRC role, including regulatory frameworks, post-market surveillance, conformity assessment routes, EUDAMED use, and best practices for interacting with Notified Bodies.
Certification & Audit Support: We help your team prepare for inspections and regulatory audits by offering practical guidance and real-world insights into what Notified Bodies look for during the certification process.
Integration into Your QMS: Our training and consulting help you embed PRRC responsibilities into your Quality Management System, creating a sustainable regulatory structure that grows with your business.
Why do you need this service?
According to Article 15 of the MDR 2017/745 and IVDR 2017/746, manufacturers must designate at least one qualified PRRC in Europe. Without it, your CE marking and market access are at serious risk.
A PRRC checks that your devices are fully compliant—avoiding penalties, recalls, and rejections by Notified Bodies.
Having a visible, qualified PRRC in your team or through a partner demonstrates your commitment to quality and patient safety. This builds trust with authorities, customers, and stakeholders.
The Person Responsible for Regulatory Compliance (PRRC) is a key role in supporting compliance for medical devices in the European market. By overseeing CE marking, documentation, and post-market activities, the PRRC helps maintain alignment with EU regulations throughout the product lifecycle.
This position adds value by reducing the risk of non-compliance and strengthening your company’s credibility with regulators, stakeholders, and customers.
Looking for PRRC Support?
Don’t take compliance risks—secure your regulatory success today. Let SOBEL Consultancy provide expert PRRC services and training, so you can stay compliant, competitive, and confident in the European market.
Whether you’re preparing for your first CE mark or scaling operations across the EU, we’re here to guide you. From hands-on PRRC services to strategic training, our approach helps you stay compliant, competitive, and confident in a highly regulated market.
Stay Compliant, Stay Competitive in the EU Market!
