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SVENSKA DENTORAMA AB

Company · Sweden

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

SVENSKA DENTORAMA AB filed 2 positions between 29 Sept 2025 and 5 Feb 2026, across 1 of the 326 legislative files tracked here.

2025 · 1 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 5 Feb 2026source

Has the EU Medical Device Regulation (MDR) improved patient safety? We beleive that its current implementation creates excessive legal, administrative, and financial burdens that hinder innovation and disproportionately affect SMEs and micro-enterprises. Manufacturers face overly demanding clinical and post-market data requirements even for long-established, low-risk devices.

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 29 Sept 2025source

The new regulatory framework / MDR is not reducing the administrative burden nor is it supporting cost-efficiency, especially for companies dealing with simple and long experineced class I and IIa products. Pateint safety in not increased by the heavy documentation burden. Micro-companies as ourselves are most probably to be forced into bankruptcy,and the market supply will be eroded and become more expensive.

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Everything on this page comes from SVENSKA DENTORAMA AB’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 If something is wrong or out of date, email info@policyspeak.com and we will correct it.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.