The EU MDR specifies that the PRRC must have appropriate qualifications and experience. Typically, the PRRC should have: - A degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline - At least one year of professional experience in regulatory affairs or quality management related to medical devices - Alternatively, four years of professional experience in these areas if no formal degree is held The PRRC can be an employee of the manufacturer or an external consultant, but they must be permanently and continuously available to perform their duties.

Navigating the Responsibilities of PRRC under EU MDR 2017/745 Explained

Jun 22
3 min read

The European Union Medical Device Regulation (EU MDR 2017/745) introduced significant changes to the regulatory landscape for medical devices in Europe. Among these changes, the requirement for a Person Responsible for Regulatory Compliance (PRRC) stands out as a critical element to ensure ongoing compliance and patient safety. Understanding the role and responsibilities of the PRRC is essential for manufacturers, authorized representatives, and importers operating under the EU MDR framework.

This article explores the key duties of the PRRC, why this role matters, and practical steps organizations can take to meet these regulatory demands effectively.

What is the PRRC and Why is it Important?

The PRRC is a designated individual within a medical device company or its authorized representative who holds accountability for regulatory compliance under EU MDR 2017/745. This role was introduced to strengthen oversight and ensure that medical devices placed on the EU market meet all safety and performance requirements.

The PRRC acts as the compliance guardian, bridging the gap between regulatory requirements and the company’s operational practices. Their involvement helps prevent non-compliance issues that could lead to product recalls, fines, or harm to patients.

Key Responsibilities of the PRRC

The EU MDR outlines specific responsibilities for the PRRC, which include:

Ensuring conformity of devices

The PRRC must verify that medical devices comply with the applicable regulations before they are placed on the market. This includes reviewing technical documentation and quality management systems.

Overseeing post-market surveillance

The PRRC monitors the performance and safety of devices after they enter the market. This involves analyzing feedback, incident reports, and ensuring corrective actions are taken when necessary.

Managing vigilance and reporting

The PRRC ensures that serious incidents and field safety corrective actions are reported to the relevant authorities within required timelines.

Coordinating regulatory submissions

They oversee the preparation and submission of documentation to notified bodies and competent authorities, ensuring accuracy and completeness.

Maintaining regulatory knowledge

The PRRC stays updated on changes in regulations, standards, and guidance documents to keep the company compliant.

Who Can Be a PRRC?

The EU MDR specifies that the PRRC must have appropriate qualifications and experience. Typically, the PRRC should have:

A degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline
At least one year of professional experience in regulatory affairs or quality management related to medical devices
Alternatively, four years of professional experience in these areas if no formal degree is held

The PRRC can be an employee of the manufacturer or an external consultant, but they must be permanently and continuously available to perform their duties.

Practical Examples of PRRC Duties in Action

To illustrate the PRRC’s role, consider these scenarios:

Pre-market device release

Before launching a new orthopedic implant, the PRRC reviews the technical file, ensuring all clinical data, risk assessments, and labeling meet EU MDR standards. Only after their approval does the company release the device.

Post-market vigilance

After reports of a rare adverse event linked to a cardiac device, the PRRC coordinates an investigation, liaises with the notified body, and submits a field safety corrective action to mitigate risks.

Regulatory updates

When the EU issues new guidance on software as a medical device, the PRRC updates internal procedures and trains the team to comply with the new requirements.

How Organizations Can Support the PRRC Role

For the PRRC to be effective, organizations should:

Provide access to resources

Ensure the PRRC has access to all necessary documentation, quality systems, and expert teams.

Encourage continuous training

Support ongoing education on regulatory changes and best practices.

Establish clear communication channels

Facilitate collaboration between the PRRC, management, and operational departments.

Define authority and independence

Empower the PRRC to make decisions and raise concerns without undue influence.

Eye-level view of a regulatory compliance officer reviewing medical device documentation in a modern office — PRRC reviewing medical device compliance documents

Challenges Faced by PRRCs and How to Overcome Them

The PRRC role can be demanding due to:

Complex regulatory environment

The EU MDR is detailed and evolving, requiring constant vigilance.

Resource constraints

Smaller companies may struggle to allocate sufficient time and personnel.

Cross-functional coordination

The PRRC must work with diverse teams, from R&D to marketing.

To address these challenges, companies can:

Use regulatory software tools to manage documentation and deadlines
Outsource certain tasks to specialized consultants when needed
Foster a culture of compliance throughout the organization

The Impact of the PRRC on Patient Safety and Market Access

By ensuring compliance, the PRRC helps protect patients from unsafe devices and supports the company’s ability to maintain market access. Non-compliance can lead to device recalls, legal penalties, and loss of reputation. The PRRC’s proactive management of regulatory obligations reduces these risks and contributes to the overall quality of medical devices.