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...
12 Tips for Effective Post-Market Surveillance Under EU-MDR
In this blog, we have provided tips to perform effective post-market surveillance under EU-MDR. What is post-market surveillance under EU-MDR? Post-market surveillance under EU-MDR is the structured process by which manufacturers continuously monitor the safety,...
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...