Dr. Juliane Havlicek

Classification of in-vitro diagnostic medical devices: how to avoid a too-high classification

By Dr. Juliane Havlicek October 10, 2024 Leave a comment

The classification of in-vitro diagnostics (IVD) can have far-reaching consequences, as it has an impact on the conformity assessment procedure, certification audits, and, thus, on market launch. To help you prevent the unnecessary allocation of your IVD product to a high-risk class, this article provides an overview of 1. What qualifies a product as an…

Details

Intended purpose and intended use: More consequences than you think!

By Dr. Juliane Havlicek August 12, 2024 Leave a comment

The correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the distinction between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…

Details

Privacy Preference

If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.

Accept all Save

Back

Essential (1)

Essential cookies enable basic functions and are necessary for the proper function of the website.

Show Cookie Information Hide Cookie Information

Name	Borlabs Cookie
Provider	Owner of this website, Imprint
Purpose	Saves the visitors preferences selected in the Cookie Box of Borlabs Cookie.
Cookie Name	borlabs-cookie
Cookie Expiry	1 Year

External Media (1)

Content from video platforms and social media platforms is blocked by default. If External Media cookies are accepted, access to those contents no longer requires manual consent.

Show Cookie Information Hide Cookie Information

Accept	YouTube
Name	YouTube
Provider	Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland
Purpose	Used to unblock YouTube content.
Privacy Policy	https://policies.google.com/privacy?hl=en&gl=en
Host(s)	google.com
Cookie Name	NID
Cookie Expiry	6 Month