Articles for the ‘Compliance’ 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

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.

In the ever-evolving world of medical device manufacturing, companies face the difficult task of ensuring innovation and progress every day. However, the pressure to use the latest technologies in healthcare is often in conflict with limited financial resources. In this complex environment, legal problems and risks often arise that can have a direct impact on pharmaceutical and medical device companies, hospitals and healthcare professionals. Pragmatic and safe legal solutions are required to resolve these issues.

We would like to offer you the opportunity to take advantage of our exclusive and free white paper on healthcare compliance.