Notified Body

Tree Model for Classification Tree Model for Classification
2019/01/10 - Medical Software - Thorsten Prinz and Isabel Jakobs

Medical Device Classification: The Software Special

The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes.

2019/01/08 - Regulatory Affairs - Cord Schloetelburg

EU MDR Factsheet for Manufacturers of Medical Devices

Medical device manufacturers must implement the new EU MDR. Here you will find an overview to get things going.

A paper with the letters MDD, the D is crossed out and an R added to make it MDR. It symbolises the transition. A paper with the letters MDD, the D is crossed out and an R added to make it MDR. It symbolises the transition.
2019/01/08 - Regulatory Affairs - Thorsten Prinz

Transition Period of the EU MDR: What Dates Manufacturers Need to Know

The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period.

European flag with scale symbolising CJEU European Court of Justice European flag with scale symbolising CJEU European Court of Justice
2019/01/07 - Regulatory Affairs - Updated: 2019/11/28 - Thorsten Prinz

CJEU Top Court Cases on Medical Devices

Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).