Strategies for successful combined (drug/device) study approvals in the EU
In vitro diagnostic tests are a key component in clinical trials with investigational medicinal products (IMP). However, many of these tests are not CE-marked or not used in accordance with their CE-mark within clinical trials. Such tests, when used for…
Combined studies and COMBINE PROJECT
Combined Studies Definition Interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and medical device regulations MDR/IVDR Update on combined projects.
Cybersecurity in Healthcare Products
The rapid advancement of medical technology brings increasing cybersecurity challenges. As medical devices and drug-device combination products integrate with wireless networks and cloud systems, they become prime targets for cyberattacks. A single breach can endanger patient safety, disrupt healthcare operations,…
Notified Bodies’ experience with Combination Products
The introduction of the MDR has brough in some additional requirements and challenges for combination products. This session will discuss the progress and learnings with examples, focussing on Article 117 combination products requiring Notified Body Opinions and Rule 14 devices…