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HHU

HUS (Helsinki University Hospital)

Other · Finland

2
positions filed
in the 326 files tracked
1
legislative file
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

HUS (Helsinki University Hospital) filed 2 positions on 6 Oct 2025, across 1 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 6 Oct 2025source

Statement on the Impact of MDR and IVDR Regulations on Healthcare Organizations and Patient Safety As a healthcare organization, we wish to express our concern that the current MDR and IVDR regulations present significant challenges to the development and implementation of innovative medical solutions.

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 2025source

Thank you for the opportunity to give feedback. One of the main root causes of the problems lies in the definition of a medical device in Article 2. The definition is very unclear and it is not unambiguous, which leads to extra work. As a result, nearly all objects and equipment used in healthcare may be interpreted as medical devices, which leads to overregulation.

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 If something is wrong or out of date, email info@policyspeak.com and we will correct it.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

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