Ronald Boumans, Global Senior Regulatory Consultant at Emergo
The European Competent Authorities are the gate keepers for the citizens in their Member State regarding medical devices. In order to do this they need to know which devices are entering their market. The current system of notification does not work adequately. In case of recall or field safety notice Competent Authorities are guessing whether that warning is of importance to their citizens. This is why some Member States require additional registration for high risk devices that are distributed on their markets, plus their distributors. The Medical Devices Regulation is introducing new legislation that will provide tools and means to Competent Authorities that will help them to supervise devices and vigilance activities in the distribution channel:
- UDI stands for ‘Unique Device Identification’. It is a code that identifies a device on two levels. The first level identifies the product, model, manufacturer etc. The second identifies the production (serial number, batch number etc.). The first is used to define the device, the second may be of use in case of a selected recall. The UDI must be placed on the label of most levels of packaging in man and machine readable formats.
- EUDAMED stands for the European Database of Medical Devices. It is a database in which data about economic operators and their devices are stored and managed. Industry will have direct access to their data and they will have to enter most of the data themselves. The public, industry, notified bodies, competent authorities and the European commission will each have their own level of access to Eudamed.
Learn about the details of UD and EUDAMED and how this impact traceability of medical devices on the European market and understand how the way devices are distributed may impact the organization of the manufacturer and may even impact the design of the device.