Articles for the ‘Healthcare’ Category

In the dynamic world of medical technology, it is essential to always be aware of the latest regulatory requirements. The introduction of the AI Act poses new legal challenges for medtech companies when using AI.

In addition, the requirements of the MDR and data protection must still be complied with, particularly with regard to the handling of sensitive health data. But how exactly does the “magic triangle” of MDR, AI Act and data protection work in medical technology?

Using practical examples we will answer this question and would like to invite you to our free webinar (in German language):

“The interplay of the Medical Device Regulation, AI and data protection in medical technology”
on Thursday, June 13, 2024
from 12:30 – 13:30
via MS Teams

Register for free today and benefit from our in-depth knowledge and expertise in the field of digital health: to the registration

In every jurisdiction the advertising of medical devices comes with certain national peculiarities. The following article explains in more detail what needs to be considered if you intend to market medical devices to the Austrian market

This blog post mainly focuses on the CJEU’s findings regarding the responsibility of parallel importers for ensuring the display of the original batch number on the product packaging.

Food law is extensively harmonized throughout the EU, but national law still has a role to play. In this short article, we look at three developments in Belgian food law that have taken place in 2023: the amendments to the Food Safety Agency’s administrative fining regime, the introduction of nutrivigilance, and the announced revision of the food hygiene legislation.

Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law.