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Boumans Regulatory Consulting B.V.

Company · Netherlands

2
positions filed
in the 326 files tracked
2
legislative files
of 326 tracked
1
with a full position paper
attached to a submission

Counts here are a floor, never a total: they cover the 326 consultation files tracked so far (29,503 submissions, mostly 2025–26), 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 326 legislative files tracked here, attaching a full position paper 1 time.

2025 · 1 filed2026 · 1 filed

What they argued

Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislationfiled 19 Apr 2026PDFsource

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.

Implementing rules regarding requirements to be met by notified bodiesfiled 31 Dec 2025source

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.

Showing 5 of 26.

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Everything on this page comes from Boumans Regulatory Consulting B.V.’s own submissions to the European Commission — we have added nothing and interpreted nothing. If something is wrong or out of date, email info@policyspeak.com and we will correct it. If you are an individual named in a record, our privacy policy sets out your rights to correction, objection and removal.

Quotes are verbatim from submissions published by the European Commission, trimmed to their opening passage and never summarized by a model. Organizations only, never individuals. Reused under Commission Decision 2011/833/EU; the European Commission is not liable for this reuse.