EUDAMED (Europejska Baza Danych o Wyrobach Medycznych) i UDI (Unikatowa Identyfikacja Wyrobów)

EUDAMED (European Database on Medical Devices) and UDI (Unique Device Identification) are integral components of the European Union’s regulatory framework for medical devices. Here’s a brief overview of each:

1. EUDAMED:
   • Purpose: EUDAMED is a comprehensive database designed to store and provide information about medical devices available on the European market. Its primary aim is to enhance transparency and coordination among EU Member States in the field of medical devices.
   • Functionality: It collects data relating to medical devices, their manufacturers, certificates, clinical investigations, vigilance, and market surveillance. This information is intended to be accessible by regulatory authorities, the industry, and the public.
   • Implementation: The development and implementation of EUDAMED is part of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It’s a key tool for ensuring a higher level of health and safety protection for EU citizens.
2. UDI (Unique Device Identification):
   • Purpose: UDI is a system used to uniquely identify medical devices through their distribution and use. It aims to improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
   • Components: A UDI typically consists of a UDI-DI (Device Identifier) which is specific to a device model, and a UDI-PI (Production Identifier) which includes information like the serial number, lot number, expiration date, and the date of manufacture.
   • Integration with EUDAMED: The UDI system is an essential part of EUDAMED, as each medical device must have a UDI that is registered in the EUDAMED database. This integration ensures traceability and accountability of devices throughout their lifecycle.

Zarówno EUDAMED, jak i UDI stanowią ważne kroki w kierunku większej przejrzystości i bezpieczeństwa w sektorze opieki zdrowotnej, zapewniając skuteczne śledzenie wyrobów medycznych i zarządzanie nimi w całej UE.