SPECTARIS welcomes the European Commission's targeted MDR/IVDR revision as an important step toward a more workable, proportionate and innovation-friendly regulatory framework, one that keeps patient safety high while easing unnecessary burden on manufacturers, notified bodies and authorities.
SPECTARIS e.V.
Industry association · Germany · EU Transparency Register 55587639351-53
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 1205 trade and business associations on this site, they rank #249 by legislative files engaged — a count of participation, not a measure of influence.
Declares membership of
- SPECTARIS is member of MedTech Europe
- SPECTARIS is a member of Euromcontact
- SPECTAROS is a member of eurom
- SPECTARIS is a member of the Umbrella Project
- SPECTARIS is a member of the FPP4EU (FluoroProducts and PFAS for Europe Sector Group) Collaboration plattform
- SPECTARIS is a member of the Silicones Europe Downstream User Platform
Self-declared to the EU Transparency Register (snapshot 30 Aug 2026).
- Register category
- Trade and business associations
- Registered as
- SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V. (SPECTARIS)
- Head office
- Berlin, Germany
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
SPECTARIS e.V. filed 7 positions between 30 Apr 2024 and 31 Jul 2026, across 6 of the 326 legislative files tracked here, attaching a full position paper 7 times.
What they argued
SPECTARIS welcomes the European Commission’s initiative on the targeted revision of Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). The medical engineering industry in Germany stands for innovation, quality and security of supply. However, the current regulatory environment is increasingly jeopardising the availability of medical devices and in vitro diagnostic medical devices in Europe.
Filed in German · English published by the European Commission
Please find attached SPECTARIS' feedback on the draft Commission guidance on the Cyber Resilience Act. SPECTARIS is the German Industry Association for Optics, Photonics, Analytical, and Medical Technology, headquartered in Berlin. The association represents approximately 400 German companies, most of which are export-oriented and medium-sized.
SPECTARIS e. V. Berlin | September 3rd 2025 POSITION Ref. Ares(2025)7177579 - 03/09/2025 SPECTARIS Position Consultation feedback On Proposal for the Omnibus Directive Aligning product legislation with the digital age - COM(2025)503 Considerations for the Optical Sector and Personal Protective Equipment About SPECTARIS SPECTARIS is the German industrial association for optics, photonics, analytical, and medical…
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
SPECTARIS ist the German industry association for optics, photonics, analytical and medical technology in Berlin. Many products made by our members - such as spectacle lenses, spectacle frames, contact lenses, medical-surgical belts, and bandages - are regulated under the Medical Devices Regulation (EU) 2017/745 and must meet high safety and quality standards.
SPECTARIS expressly welcomes the draft Implementing Regulation for Annex VII to the MDR/IVDR and sees it as an important step towards further stabilising and strengthening the European regulatory framework for medical devices and in vitro diagnostic medical devices.
Filed in German · English published by the European Commission
-See attachment- SPECTARIS e.V. supports the European Commission's proposals to improve and harmonize EU regulations for dual-use goods, as outlined in the White Paper on Export Controls. The strengthening of uniform controls and the introduction of new coordination mechanisms to ensure security and competitiveness in the EU are particularly welcomed.
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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.
- APPLiA - Home Appliance Europe · 4 files in common
- DIGITALEUROPE · 3 files in common
- Bitkom e.V. · 3 files in common
- Japan Business Council in Europe · 3 files in common
- VDMA · 3 files in common
Showing 5 of 60.
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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.