What´s the real added value of a PRRC?

The Person Responsible for Regulatory Compliance (PRRC) is a role defined in Article 15 of the Hashtag#MDR and Hashtag#IVDR. It sounds official, and it is, but what value does the PRRC add to an organisation?

Many people assume the PRRC is someone who 𝘥𝘰𝘦𝘴 all the compliance tasks. But that’s not quite right. For example, the PRRC must ensure that the declaration of conformity has been drawn up. But drawing it up and signing it? That might be part of another role. The PRRC doesn’t create the declaration. Instead, they verify that it exists, that it contains the correct information, and that it’s been signed by the right person (and no, that’s not necessarily the PRRC either). And if the person with the role of PRRC does all this, they’re doing so from another role.

So what does „ensuring“ really mean? It means being the final checkpoint; the person who knows where to look, what to question, and when to speak up.
For upper management, this role is essential. A strong PRRC means that leadership can:

• Be confident that their devices are (and remain) market-ready
• Sleep better knowing someone is tracking compliance risks proactively
• React in time when something goes wrong, because someone is watching closely and knows what to do
• Know that the person with an ear to the ground on the work floor reports directly to them

This isn’t just about regulatory requirements. It’s about trust, timing, and business continuity. That’s why we need to rethink the title. Rather than referring to the PRRC as some bureaucratic function, let’s call them what they really are:

Captain Confidence:

• The one who keeps the ship steady when regulations shift.
• The one who verifies that what’s supposed to happen, actually happens.
• The one leadership can rely on to warn about an issue long before it becomes a problem.

Of course, every PRRC has to earn that title by stepping up, speaking clearly and keeping compliance policies on track.
Let’s be honest: the role deserves more recognition and more clarity. So here’s to you, the Super PRRC out there, or should we say…

Captain Confidence.