In order to reform legislation on medical devices, the European Commission has adopted two regulations, which have been in force since May 2021. The first, Regulation (EU) 2017/745, pertains to medical devices. The second, more specific Regulation (EU) 2017/746 targets in vitro diagnostic medical devices. The European regulation of medical devices can be confusing to implement.
Safety and performance on the agenda
The collection of data from clinical investigations on medical devices is subject to the same conditions as those of clinical trials for drug candidates. For implantable medical devices, manufacturers will need to provide an implant card. It must provide the medical device’s identification in the form of its name, serial and batch numbers, manufacturer’s contact details and the expected lifetime of the device.
The traceability of medical devices throughout the entire supply chain is central to this regulation. The regulation establishes a system for registering the MD, manufacturers, importers and representatives using a unique device identifier (UDI). This identifier is made up of two distinct components. The first identifier, the UDI-DI, refers to the device while the second, the UDI-PI, pertains to production.
However, it is important to note that the UDI supplements but does not replace labelling requirements for MD. The aim is to improve the traceability of the MD, facilitate recalls, effectively combat counterfeiting and, above all, improve patient safety. In order for this to be improved, all information will be entered into the European Medical Devices Database, EUDAMED.
But what is the manufacturer’s role?
Before placing a medical device on the market, manufacturers are required to assign a UDI-DI and register it in the Eudamed database. They must be careful to assign a UDI that matches the medical device’s class, since this determines all the standards to be applied. The obligation to submit UDI data in Eudamed comes into force on 26 November 2022 for medical devices and on 26 November 2023 for in vitro diagnostic medical devices.
Although manufacturers’ new obligations are more stringent, they do successfully reinforce quality monitoring and the performance and safety of medical devices.
Need advice on how to assign a UDI to your MD and register it in Eudamed? Contact us today. We put our expertise to work to help you find the best solution for your situation.
European Medical Device Regulation 2017/745
For more details, download REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL