Find out how much EU MDR compliance costs: between 5% and 15% of manufacturers' annual turnover, with a major impact on SMEs.

The European Medical Devices Database, better known as EUDAMED, plays a fundamental role in the regulation of medical devices within the European Union. Established by the European Commission, EUDAMED aims to centralize information related to the traceability, safety, and compliance of medical devices placed on the European market. Its main objective is to increase transparency and improve post-market surveillance, while facilitating the exchange of information between manufa

With less than two weeks remaining before the EU MDR UDI deadline, Class I medical device manufacturers are still making preventable—but critical—errors. These mistakes are not just technical hiccups. They reflect deeper issues in data governance and can directly compromise regulatory compliance. Here are the five most frequent mistakes  still observed in the field: 1. Improperly Structured or Undeclared GTINs Many manufacturers are using generic GTINs without having official

The EU Medical Device Regulation (MDR 2017/745) has fundamentally reshaped how Class I medical devices are labeled and tracked. One of the most overlooked – yet critical – areas of compliance is the UDI Carrier Label . As of 26 May 2025 , all Class I devices must display a UDI  (Unique Device Identifier) on their labels and higher packaging levels. But here's the catch: many small or craft-scale manufacturers are unaware , overwhelmed, or misinformed about what this actually