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.
HUS (Helsinki University Hospital)
Other · Finland
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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
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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