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...
CE Marking for Class I, II, and III Medical Devices: A Guide
CE marking is a mandatory requirement for medical devices sold in the EU/EEA. It demonstrates compliance with EU MDR safety, performance, and quality requirements. The process involves classification, conformity assessment, technical documentation, and post-market...
A Guide to CE Mark For Medical Devices: What, How, & Why
To secure CE mark, the manufacturer is expected to ensure all EU-wide requirements for the medical device have been complied. If the device complies with strict safety, health, and environmental protection benchmarks, it may be granted the CE mark certification....