Mikrobiologi.net/FKM

Mikrobiologi.net > FKM > Nyheter > (1174)  
ESCMID-enkät om IVDR
Som till ESCMID associerad förening har denna enkät inkommit där ESCMID önskar information om hur impementering av IVDR upplevts Se nedan för information.


Dear Colleagues,



At ESCMID, we understand that the new In Vitro Diagnostic Regulation (IVDR) has a significant impact on microbiological diagnostic methods. In response, Dr. Gülsen Özkaya Sahin represents ESCMID on the Steering Committee of the Biomedical Alliance’s IVDR Task Office.



Dr. Sahin has recently discussed IVDR-related challenges with BioMed Alliance. These conversations have highlighted serious concerns for clinical microbiology laboratories across Europe, including:

• A complex and demanding certification process

• High financial costs

• Difficulties in certifying in-house developed diagnostic tests



Through the Biomedical Alliance, Dr. Sahin continues to communicate with the European Commission. Her goal is to represent the concerns of European laboratories and to keep ESCMID members informed about updates and activities related to IVDR.

To support this important work, we would like to gather broader input from our affiliated societies. This will help us present a clearer picture to the European Commission, together with our colleagues in the Biomedical Alliance.



We kindly ask you to share a short survey (https://escmid.wufoo.com/forms/new-ivdr-implementation-feedback-form/) questionnaire with your members. The survey takes approximately 3–4 minutes to complete, and we request one response per hospital, if possible. If we receive strong participation, we plan to publish the findings to highlight the impact of IVDR—without naming individual hospitals or countries.

Thank you very much for your attention and support. With your help, we have a real opportunity to influence these regulations. The more responses we receive, the stronger our collective voice will be.



Warm regards,

Gülsen Özkaya Sahin represents ESCMID



Send by Magdalena Krzyzaniak

Magdalena Krzyzaniak

, PhD

Science Manager

ESCMID

 

Mer information: Länk
« Tillbaka
Inlagt 2025-08-13 av Torgny Sunnerhagen  


2026-04-30 16:04
Ⓒ Allt material på denna webbplats skyddas av upphovsrättslagen.
Upphovs- och förfoganderätten tillhör Mikrobiologi.net och respektive upphovsman