Over the past months, we have seen a growing number of manufacturers reaching out with questions about the Person Responsible for Regulatory Compliance (PRRC). In many cases, the initial question is straightforward: Who can act as our PRRC under MDR or IVDR?
Very quickly, the discussion often expands. Manufacturers are not only looking to formally appoint a PRRC, but also to ensure that their technical documentation, processes, and regulatory activities genuinely meet current expectations.
This is where the PRRC role becomes more than a regulatory formality.
Why the PRRC role matters
Under the EU MDR and IVDR, all medical device and IVD manufacturers are required to designate a Person Responsible for Regulatory Compliance (PRRC). The role is designed to ensure that regulatory compliance is embedded into day-to-day operations, rather than handled as an afterthought.
In practice, the PRRC oversees key areas such as:
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conformity of devices and technical documentation,
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post-market surveillance and vigilance activities,
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regulatory reporting and communication,
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and alignment of quality and regulatory processes.
Notified bodies and competent authorities increasingly expect the PRRC to be competent, accessible, and actively involved. Simply naming a person on paper is no longer sufficient.
External PRRC support as a practical solution
While all manufacturers must designate a PRRC, not all organisations are in a position to fulfil the role internally. For many companies, appointing an external PRRC is a practical and effective solution.
External PRRC support provides access to experienced regulatory professionals without the need to build or maintain full in-house capacity. It can also improve continuity and independence, particularly during periods of growth, staff changes, or increased audit activity.
At MDS, our PRRC service is designed to integrate closely with your team. We work as a regulatory partner, not just as a named role holder.
PRRC support linked to real documentation work
One of the most common challenges we see is that the PRRC role is treated as separate from documentation activities. In reality, the two are closely connected.
An effective PRRC must have a clear and up-to-date understanding of:
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the structure and content of technical documentation,
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how documentation is maintained and updated,
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and how changes to devices are reflected across risk management, clinical evaluation, and post-market documentation.
As part of our PRRC service, MDS also supports manufacturers with updating existing documentation and creating documentation for new or modified devices. This ensures that regulatory oversight is supported by documentation that is complete, consistent, and aligned with current MDR and IVDR expectations.
Supporting new and evolving devices
Regulatory responsibilities do not end once a device is CE marked. Design changes, process improvements, software updates, and expanded intended use all trigger documentation updates that require careful regulatory oversight.
By combining PRRC support with hands-on documentation expertise, manufacturers can manage change in a controlled and compliant manner. This reduces regulatory risk and supports smoother interactions with notified bodies.
A proactive approach to regulatory compliance
When used effectively, the PRRC role becomes a central point of regulatory confidence within an organisation. It supports clearer accountability, better internal decision-making, and stronger preparedness for audits and inspections.
At MDS, we help manufacturers move beyond formal compliance and build regulatory structures that work in practice.
How MDS can support you
MDS Finland provides PRRC services under MDR and IVDR, supported by deep expertise in technical documentation, clinical evaluation, and quality management systems.
Whether you are appointing a PRRC for the first time, reassessing your current setup, or preparing documentation for new or improved devices, we are ready to support you.
Contact us at sales@mdsfinland.com or schedule a consultation via Book a Meeting.
