Subject: Public consultation IVDR
From: "ECDC Microbiology" <[email-masked]>
To: "Indra Alexander" <[email-masked]>, "Apfalter Petra" <[email-masked]>, "Wesley.Mattheus" <[email-masked]>, "steven.vangucht" <[email-masked]>, "ivanoov" <[email-masked]>, "stefka.krumova" <[email-masked]>, "ljiljana.zmak" <[email-masked]>, "selma.bosnjak" <[email-masked]>,Ivana Ferenčak <[email-masked]>, "m.mendris" <[email-masked]>, "Fani Theophanous" <[email-masked]>, "dpieridou" <[email-masked]>, "ckaragiannis" <[email-masked]>, "Zuzana Okonji" <[email-masked]>
Cc: "NC_CCB_Austria" <[email-masked]>, "sigrid.kiermayr" <[email-masked]>, "koen.blot" <[email-masked]>, <[email-masked]>, "Julien Sohier" <[email-masked]>, "Zhivka Getsova" <[email-masked]>, "Iva Christova" <[email-masked]>, "kcapak" <[email-masked]>, "bernard.kaic" <[email-masked]>, "Elisavet Constantinou" <[email-masked]>, "Czech Republic Generic Email Box -" <[email-masked]>,Hana Orlíková <[email-masked]>,Kamilla Grønborg Laut <[email-masked]>, "Stine Ulendorf Jacobsen" <[email-masked]>,Kärt Sõber <kart
Date: Fri, 14 Mar 2025 16:16:39 +0200

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

To: National Focal Points for Microbiology (members/alternates)

cc. National Coordinators (members/alternates)

Dear National Focal Points for Microbiology,

Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 
2017/746 on in vitro diagnostic medical devices (IVDR) were adopted in 2017. 
The Regulations aim to ensure that only safe and effective devices are on 
the EU market, to protect patient safety and public health while supporting 
innovation.

Considering the extent of the changes introduced by the Regulations, 
transition periods were envisaged to ensure a smooth transition to the new 
rules. These transition periods continue to apply and due to some 
challenges, have been extended. In view of the significant challenges 
encountered in transitioning to the new rules the Commission has decided to 
launch a targeted evaluation of the Regulations in 2024.

As part of this evaluation the European Commission has opened a public 
consultation to receive feedback on the regulation and its impact.

EU rules on medical devices and in vitro diagnostics – targeted evaluation 
<https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14155-EU-rules-on-medical-devices-and-in-vitro-diagnostics-targeted-evaluation_en>

We kindly encourage you to provide feedback on this evaluation or share the 
link with colleagues who have an interest in this topic and are willing to 
contribute. Please be advised that the deadline for submitting feedback is 
21 March 2025.

Kind regards,

Daniel Palm

on behalf of the ECDC Microbiology 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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