Thank you for the possibility of commenting the Proposal for amendment of MDR and IVDR. We understand the complexities that small medical device and IV device manufacturers are facing in meeting the reguirements of the Regulations.
SGS Fimko Oy
Company · Finland · EU Transparency Register 425814793524-47
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.
Who they are
Among the 145 other organisations on this site, they rank #80 by legislative files engaged — a count of participation, not a measure of influence.
Declares membership of
- Helsingin seudun kauppakamari
- Sanastokeskus ry
- Suomen valoteknillinen seura ry
- SFS Suomen standardit ry
- Sähköinen liikenne ry
Self-declared to the EU Transparency Register (snapshot 30 Aug 2026).
- Register category
- Other organisations
- Registered as
- Sähkötekniset standardit Suomessa SESKO ry (SESKO ry)
- Head office
- Helsinki, Finland
Self-declared to the EU Transparency Register (snapshot 30 Aug 2026); cost bands are floors, not audited totals. Reused under Commission Decision 2011/833/EU.
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Their record over time
SGS Fimko Oy filed 2 positions between 23 Jan 2026 and 15 May 2026, across 2 of the 326 legislative files tracked here, attaching a full position paper 2 times.
What they argued
The proposal is intended to bring welcome predictability to the timelines of the MDR and IVDR certification. However, it appears that - there has been almost no impact assessment done to the effects of the proposal and - the scope of the proposal exceeds the legislative purpose that is intended for Implementing Acts.
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Turns up on the same files
Organizations that also filed on at least two of the same consultations. A shared interest in the same dossiers — not evidence of coordination, and we do not suggest any.
- MedTech Europe · 2 files in common
- EURAMET e.V. · 2 files in common
- TÜV-Verband e. V. · 2 files in common
- Cruelty Free Europe · 2 files in common
- Pharma Deutschland e.V. · 2 files in common
Showing 5 of 26.
Is this your organization?
Everything on this page comes from SGS Fimko Oy’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 If something is wrong or out of date, email info@policyspeak.com and we will correct it.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.