Medical Device Regulation (MDR) Software Overclassification Rule 11 of MDR effectively classifies nearly all healthcare software as at least a Class II device. In contrast, other jurisdictions exempt software meeting the definition of clinical decision support.
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Epic Systems
Company · United States · EU Transparency Register 414574852633-53
4
positions filed
in the 665 files tracked
4
legislative files
of 665 tracked
3
with a full position paper
attached to a submission
Counts here are a floor, never a total: they cover the 665 consultation files tracked so far (57,774 submissions, mostly 2021–26), so an organization's real filing history is larger, not smaller.
Who they are
Among the 1210 companies & groups on this site, they rank #387 by legislative files engaged, a count of participation, not a measure of influence.
0.5
declared lobbying FTE
self-declared
€200K+
declared costs / yr (floor)
0
EP accreditations
as declared to the register
2024
in the register since
Declares membership of
- DIGITALEUROPE https://www.digitaleurope.org/
Self-declared to the EU Transparency Register (snapshot 14 Oct 2026).
- Register category
- Companies & groups
- Head office
- Verona, United states
- EU office
- Bristol
Self-declared to the EU Transparency Register (snapshot 14 Oct 2026); cost bands are floors, not audited totals. Reused under Commission Decision 2011/833/EU.
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Their record over time
Epic Systems filed 4 positions between 11 Oct 2025 and 29 Sept 2026, across 4 of the 665 legislative files tracked here, attaching a full position paper 3 times.
2025 · 1 filed2026 · 3 filed
What they argued
We appreciate the opportunity to provide feedback on the Commissions draft Guidance on the Cyber Resilience Act (Regulation (EU) 2024/2847). We support the Commissions mission to raise the cybersecurity posture of the products made available in the EU and EEA to protect citizens and Member States from threats against the confidentiality, integrity, and availability of information.
Timeline to Release Technical Documentation Article 5.4 states that specifications will be released "sufficiently in advance of the start of those checks to enable the entities concerned to prepare their system and connection." Given the overall deadline to start exchanging data in early 2029, providing specifications much later than the finalised implementing acts will already put some vendors and Member States at…
Epic, a global healthcare technology company working hospitals and clinics throughout the EU and EEA, welcomes the opportunity to comment on the draft Implementing Regulation on minimum metadata elements for dataset descriptions under the EHDS. Full reasoning and recommendations are provided in the attached submission. This response summarises our principal concerns. Single authoritative source.
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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.
Showing 5 of 54.
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Everything on this page comes from Epic Systems’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.