Subject: IVDR: Call for Evidence
From: "ECDC respiratory viruses" <[email-masked]>
Cc: "ECDC Info" <[email-masked]>
Date: Thu, 11 Sep 2025 10:36:50 +0300

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu 
saatja korral palume linke ja faile mitte avada.

To:  National Focal Points for Viral Respiratory Diseases, Operational 
Contact Points for influenza, Covid -19 and SARI (microbiology)
Cc:  National Coordinators

Dear Network Members,

The European Commission has launched an open consultation to gather feedback 
on the targeted revision of EU rules for medical devices and in vitro 
diagnostics (MDR/IVDR). This initiative aims to simplify the regulatory 
framework while maintaining high standards of patient safety and public 
health.

The consultation is open from 8 September to 6 October 2025, and your input 
is highly valued. Feedback from stakeholders is critical to ensure that 
future regulatory changes are informed, balanced, and responsive to 
real-world challenges.

We strongly encourage you to contribute your perspectives to help shape the 
next phase of EU medical device regulation.

Medical devices and in vitro diagnostics – targeted revision of EU rules 
<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>

Kind Regards,

The ECDC Respiratory Viruses Team

European Centre for Disease Prevention and Control (ECDC)

Gustav III:s boulevard 40, 169 73 Solna, Sweden

Phone +46 (0)8 58 60 10 00

 <https://www.ecdc.europa.eu/> www.ecdc.europa.eu

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