Understanding Eudamed, UDI, and MDR: A Guide for Medical Device Manufacturers
In the medical device industry, compliance with regulatory requirements is crucial for ensuring patient safety and product quality. One important aspect of compliance is tracking and reporting information about medical devices, including their unique identification, classification, and post-market surveillance. This is where the concepts of Eudamed, UDI, and MDR come into play.
What is Eudamed?
Eudamed (European Database on Medical Devices) is an electronic database that is being developed by the European Commission (EC) as part of the implementation of the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Devices Regulation (IVDR). Eudamed will serve as a central repository of information on medical devices that are placed on the market in the European Union (EU).
What is UDI?
UDI, or Unique Device Identification, is a system of coding and labeling medical devices with a unique identifier that allows for the identification and traceability of individual devices throughout their lifecycle. UDI is a key component of the MDR and is intended to improve patient safety by facilitating the recall of faulty or problematic devices and enabling the identification of individual devices in the event of adverse events.
What is MDR?
MDR, or Medical Devices Regulation, is a new regulatory framework that replaces the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) in the EU. The MDR introduces new requirements for medical device manufacturers, including mandatory reporting to Eudamed, the use of UDI, and increased clinical evidence requirements, among others.
By understanding Eudamed, UDI, and MDR, medical device manufacturers can ensure that they are fully compliant with the latest regulations and are able to provide safe and effective medical devices to patients in the EU.
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