What is Medical Device Equivalence? A Detailed Guide
Medical device equivalence is a regulatory concept under the EU Medical Device Regulation (MDR). It allows a manufacturer to rely on the clinical data of an already marketed device to support the safety and performance of a new device. However, they must demonstrate...
CE Marking of Digital Health Technologies: EU MDR Guidelines
Digital health technology is the integration of digital tools into healthcare to improve prevention, diagnosis, monitoring, and treatment. CE marking of digital health technologies is mandatory under the EU Medical Device Regulation (MDR). It ensures that software,...
CE Marking for Ophthalmic Medical Devices
Ophthalmic medical devices are specialized instruments and equipment used to diagnose, monitor, and treat eye conditions. These devices range from simple diagnostic tools to advanced therapeutic and surgical products. CE marking is critical for ophthalmic medical...