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opTricon GmbH

Company · Germany

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

opTricon GmbH 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

Ladies and gentlemen, I would like to argue that the new requirements under Implementing Regulation (EU) 2025/1234 with regard to eIFU, which currently apply only to the MDR, should be extended to the IVDR. The POCT/patient near-patient use of class A devices by exclusively professionally trained staff is not explicitly considered and should be: The need for a printed IFU is assessed in a similar way as in…

Filed in German · English published by the European Commission

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

Ladies and gentlemen, I would like to argue that the new requirements under Implementing Regulation (EU) 2021/2226 regarding eIFU, which currently apply only to the MDR, should be extended to the IVDR. The POCT/patient near-patient use of class A devices by exclusively professionally trained staff is not explicitly considered and should be: The need for a printed IFU is assessed in a similar way as in…

Filed in German · English published by the European Commission

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