Article 15 about the Person Responsible for Regulatory Compliance (PRRC) does not specify what the PRRC should, how, and who they should report to. This results in confusion and in my daily work I see PRRCs struggling with with lack of clarity. This often does not have a positive effect on the safety of medical devices. Attached is my take on Article 15.
BRC
Boumans Regulatory Consulting B.V.
Company · Netherlands
not in the EU Transparency RegisterThis organization files on consultations without a register number, so its record here is built from its filings alone. Register facts (staff, costs, accreditations) are not available for it.
2
positions filed
in the 665 files tracked
2
legislative files
of 665 tracked
1
with a full position paper
attached to a submission
Counts here are a floor, never a total: they cover the 665 consultation files tracked so far (57,774 submissions, mostly 2021–26), so an organization's real filing history is larger, not smaller.
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Their record over time
Boumans Regulatory Consulting B.V. filed 2 positions between 31 Dec 2025 and 19 Apr 2026, across 2 of the 665 legislative files tracked here, attaching a full position paper 1 time.
2025 · 1 filed2026 · 1 filed
What they argued
As a consultant, I support manufacturers in preparing technical documentation. I have been doing this for many years. As a result, the documentation I am involved in often passes completeness checks without comments. That is rarely where the difficulty lies. The problem often starts afterwards.
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Turns up on the same files
Organizations that also filed on at least two of the same consultations. A shared interest in the same dossiers, not evidence of coordination, and we do not suggest any.
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