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OpenRegulatory (OpenReg GmbH)

Company · Germany

2
positions filed
in the 326 files tracked
2
legislative files
of 326 tracked
0
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

OpenRegulatory (OpenReg GmbH) filed 2 positions on 26 Sept 2025, across 2 of the 326 legislative files tracked here.

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 26 Sept 2025source

While many people here have shared thoughtful feedback, we think that the elephant in the room is being overlooked: The MDR is fundamentally broken, and the EU is failing in its role in nearly every aspect. We (OpenRegulatory) are a consultancy and eQMS software provider, focusing mainly on startups; arguably, there might be no other company in the EU which has been as exposed as we have to the struggles of…

28th regime corporate legal framework – EU Inc.filed 26 Sept 2025source

While there be many nitty-gritty reasons on why this proposal might not be a good idea, mostly concerning harmonization of national laws etc., let me share our perspective as an organization which meets new Healthcare founders and their startups on a daily basis: Every week, I meet at least one founder who plans to leave the EU due to the sum of its prohibitive bureaucracy it has accumulated over the last few years.

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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 8.

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Everything on this page comes from OpenRegulatory (OpenReg GmbH)’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 If something is wrong or out of date, email info@policyspeak.com and we will correct it.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.