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Käesolevaga edastan Eesti Laborimeditsiini Ühingu (ELMÜ) pöördumise seoses IVDR määruse artikliga 5.5

Lugupidamisega

Katrin Reimand

ELMÜ sekretär

To: Presidents and National Representatives of National Societies’ Members of EFLM

IVDR revision: URGENT call for National input and support of the EFLM position

Dear EFLM National Societies’ Representatives,

Currently the European Commission is preparing a planned revision of the IVDR. For that reason they have asked all national standard institutes to gather feedback on the current version.

Within EFLM, our Commission on European Regulatory Affairs (C-ERA) has a long tradition in gathering input for required revision and wording of such feedback. Recently they have formulated an important call for revision (ref 1). The EFLM Division for Quality, Standards and Regulations (D-QSR) and its Committee on Accreditation and ISO/CEN Standards fully endorse that call.

On behalf of EFLM, we kindly, but urgently, ask you to use your contact in the relevant committee of your national standard institute

to answer the call for input for revision of the IVDR with the paper in ref 1. Feedback can only be submitted by October 6 using this link:

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en

We believe that by sending the same message from multiple sources will make our voices better heard then when we all try to word our feedback in our own words and dilute it with other messages.

Other messages can, if needed, be sent by others. Please use your national societies voice to support the EFLM C-ERA message, based on the long standing work of experts in this field.

Thanks in advance you for your cooperation!

Mario Plebani

EFLM President

ref 1.

Cobbaert C, Schweiger C, Buchta C, Streichert T, Vanstapel F, Mullier F, Biaggini L, Capoluongo E, Bossuyt P, Bhattoa HP, Melvin T, Neumaier M; EFLM Committee on European Regulatory Affairs (EFLM C-ERA) and endorsed by the DGKL Board. Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics. Clin Chem Lab Med. 2025 Aug 20. doi:10.1515/cclm-2025-1033. Epub ahead of print. PMID: 40827911.

https://www.degruyterbrill.com/document/doi/10.1515/cclm-2025-1033/html

_______________________________________

Silvia Cattaneo - EFLM Office

European Federation of Clinical Chemistry

and Laboratory Medicine (EFLM)

Via Carlo Farini, 81 - 20159 Milano - ITALY

[email protected]
Tel: +39-389-5320051

wwww.eflm.eu

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