The European Union Medical Devices Regulations (EU MDR) replaces the Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC. The EU MDR includes a series of critical improvements to modernize the current system and streamline scientific progress that has occurred in the medical device space over the last 20 years. It prioritizes the safety of medical devices through more robust clinical evidence, post-market surveillance, and information transparency. The new regulations apply to all medical device manufacturers who are looking to place their products in the EU market. Since by May 2025 the devices that were CE Marked under the MDD may no longer be marketed in EU, medical device OEMs need a strong partner for compliance.
Cyient supports the complete transition from MDD to MDR—from gap assessment through post-market surveillance, technical documentation including Design History File (DHF), and Risk Management File (RMF) preparation. With hands-on experience in successfully implementing MDR projects for our clients, we are well positioned to support companies through their MDR compliance journey.
*Reference Official Journal of the European Union (OJEU)