6 Key EU MDR Requirements for SaMD & How to Comply?
EU Medical Device Regulation (EU MDR) has placed the Software as a Medical Device (SaMD) under a strict risk-based framework (EU MDR Rule 11). EU MDR broadened the scope for SaMD compared to the old Medical Device Directive (MDD). Many software products previously...
EU MDR Guidelines for Drug-Device Combination Products
The EU Medical Device Regulation (MDR) categorises drug-device combinations based on their primary mode of action (PMOA). The regulatory pathway is determined by whether the product is primarily a medicinal product (drug) or a medical device. In this blog, we will...
10 Tips to Effectively Navigating EU MDR Compliance Challenges
Navigating EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is proving to be one of the most complex regulatory challenges for manufacturers. We have presented some of the common EU MDR compliance challenges. Additionally, we have provided...