Decomplix

Medical device and IVD Vigilance in EU and Switzerland. Read all about the requirements relative to the reporting of device-related issues to competent authorities in our new blog article.


sitem-insel

Medical device and IVD Vigilance in EU and Switzerland - Decomplix If you place medical devices and IVDs on the market in the EU and/or Switzerland, you must understand the requirements relative to the reporting of device-related issues to competent authorities. The terminology, reporting criteria, and timelines in the EU MDR/IVDR have evolved from the former Direc...

Medical device “labelling” language requirements under EU MDR and IVDR? A challenge with 20 languages to consider. Here's all you need to know about it.


sitem-insel

Medical device “labelling” language requirements under the EU MDR and IVDR - Decomplix In the following blog post, you will get practical answers on how the languages are regulated in the MDR.

Have you heard about the Swiss authorised representatives for medical device manufacturers? You can find all you need to know in the latest update to our blog article.


sitem-insel

Swiss Authorized Representatives for Medical Device Manufacturers - Decomplix Have you heard about Swiss Authorized Representatives for medical device manufacturers yet? Here is all you need to know about it.