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BGN

BSI Group The Netherlands B.V.

Other · Netherlands

2
positions filed
in the 665 files tracked
1
legislative file
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

BSI Group The Netherlands B.V. filed 2 positions between 6 Oct 2025 and 24 Jul 2026, across 1 of the 665 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 24 Jul 2026source

BSI welcomes the Commissions efforts to improve the efficiency and predictability of the MDR and IVDR, particularly through measures supporting breakthrough and orphan devices, digitalisation, and enhanced regulatory cooperation.

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 6 Oct 2025PDFsource

BSI has more than 30 years experience as a full scope EU Notified Body, UK Approved Body, MDSAP Auditing Organisation, ISO 13485 Certification Body, Registered Certification Body for the PMDA and supports conformity assessment to authorities in more than 12 other countries.

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Everything on this page comes from BSI Group The Netherlands 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 If something is wrong or out of date, email info@policyspeak.com and we will correct it.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.