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EEA

EAAR - European Association of Authorised Representatives

Industry association · Belgium

2
positions filed
in the 665 files tracked
1
legislative file
of 665 tracked
2
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.

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Their record over time

EAAR - European Association of Authorised Representatives filed 2 positions between 6 Oct 2025 and 12 May 2026, across 1 of the 665 legislative files tracked here, attaching a full position paper 2 times.

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 12 May 2026PDFsource

Members of EAAR act as independent Authorised Representatives on behalf of thousands of non-EU manufacturers. EAAR believes that the additional flexibility introduced by the proposed change to Article 11 is positive and provides new efficient options for the manufacturers.

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 6 Oct 2025PDFsource

Members of EAAR act as independent Authorised Representatives on behalf of thousands of non-EU manufacturers. EAAR offers its contribution on the following aspects: 1) Improvement of AR involvement in EUDAMED Device Registration, 2) Clarity on the verification requirement for ARs, 3) Clarity on AR involvement in vigilance matters, 4) Rewording of liability for ARs.

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Everything on this page comes from EAAR - European Association of Authorised Representatives’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 If something is wrong or out of date, email info@policyspeak.com and we will correct it.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.