MedTech Europe’s Guidance on Basic UDI-DI Assignment
The MedTech Europe renders its Basic UDI-DI guidance document public for the benefit of all stakeholders involved in the Basic UDI-DI assignment and assessment such as manufacturers, system or procedure pack producers, issuing agencies and notified bodies.
The guidance primarily aims to provide a framework for companies to help their Basic UDI-DI assignment as per Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The document describes the legal and other connected rules – mainly arising from the EUDAMED database design – that are essential to understand before making decision on the Basic UDI-DI grouping. Being a European concept, the Basic UDI-DI guidance provides useful information for stakeholders outside of the EU.
Posted on 02.06.2020