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IVD manufacturer

Company · Netherlands

3
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

IVD manufacturer filed 3 positions between 23 Sept 2025 and 15 Apr 2026, across 1 of the 326 legislative files tracked here.

2025 · 2 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 1 Oct 2025source

We appreciate the Commission's initiative to simplify EU regulations for in vitro diagnostic (IVD) medical devices. Firstly, as has been pointed out, the cost of certification has risen exponentially for SMEs. This is reflected in notified body (NB) fees - both pre- and post-market - and the significant human resources required for data collection.

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 23 Sept 2025source

Implementing future requirements for in vitro diagnostic medical devices will entail considerable costs for our manufacturers. This could have the following consequences: 1. The discontinuation of further devices, which can lead to a reduction in diagnostic diversity and thus to a deterioration of patient care. 2.

Filed in German · English published by the European Commission

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