One of the biggest challenges for companies in the general wellness space is understanding how and when their technology might encounter FDA regulatory scrutiny.
Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. The current In Vitro Diagnostic Devices Directive (98/79/EC), which dates from 1998, has been thrown out the window and will be replaced by the IVDR 2017/746.
Are you marketing a companion diagnostics (CDx) product? If so, you already know two things: first, CDx products are powerful tools in precision medicine. Second, they come with some unique regulatory challenges because they are considered pharmaceuticals and medical devices.
It's finally here. The European Commission's new In Vitro Diagnostic Regulation (IVDR 2017/746) will address several weaknesses of the IVDD and bring significant regulatory changes for IVD manufacturers selling in Europe. The IVDR will apply from 26 May 2022, but proactive IVD companies are planning their implementation strategies now.
Selling your medical device in the global marketplace requires you to consider other languages and cultures. There are over 20 official languages in Europe alone and thousands more worldwide. How is it possible to provide necessary information about your medical device to a diverse group of users?
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