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SARS-CoV-2

Informações de teste
April 2022
Cepheid IVDR Communication

Dear Valued Customers,

When the new In Vitro Diagnostic Medical Devices Regulation (IVDR)1 officially comes into force on 26 de maio de 2022, it will create a robust, transparent, and sustainable regulatory framework that will improve clinical safety, create fair market access for manufacturers, and increased transparency for users, including patients.2

A recent amendment by the European Commission to the implementation of the IVDR,3 while maintaining the date of application, allows some existing products (excluding class A non-sterile devices which correspond for Cepheid to systems and collection devices) to continue to be placed on the market in compliance with the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD). The amendment extends the IVDR transitional provisions by 3-6 years, depending on IVD risk classes.

At Cepheid, we have been running a cross-functional, global program to implement the new IVDR requirements since 2019. We know how crucial it is to successfully manage this transition. We are fully committed to supporting all our customers by maintaining product availability to healthcare professionals and, ultimately, patients.

If Cepheid withdraws a product from the market, we will proactively notify our customers at least six months in advance, whether this happens in the context of IVDR or for other reasons.

Thank you for your continued business and interest in our products. We appreciate the partnership we have formed and will continue to strive to bring you the highest quality systems and tests in the industry.

If you have any questions or concerns about the transition, please contact Anne Postulka, Senior Director Regulatory Affairs, EMEA at anne.postulka@cepheid.com.

Best regards,

Rika Dutau
Vice-President, General Manager, EMEA Commercial Operations

 

1. In Vitro Diagnostic Medical Devices Regulation (IVDR) (2017/746/EU). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746. Accessed in October 2019.
2. Comissão Europeia. 2018. Factsheet for Manufacturers of in vitro Diagnostic Medical Devices. ISBN: 978-92-79-90405-9. DOI: 10,2873/850249. Access in October 2019.
3. EUR-Lex - 52021PC0627 - EN - EUR-Lex (europa.eu)
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