In brief
From 26 May 2022, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has applied.
Key takeaways
- The main changes introduced by the IVDR include (i) a new classification of devices, which are divided into Classes A, B, C and D according to their intended use and risks to the individual and public health, (ii) new conformity assessment procedures that differ according to the risk class and the specific characteristics of the device, (iii) reinforced requirements relating to clinical evidence aimed at demonstrating compliance with the safety and performance requirements of the device, depending on its characteristics and intended use, (iv) the introduction of post-marketing follow-up obligations for manufacturers aimed at updating the performance evaluation throughout the life cycle of the device, (v) the provision of new obligations for manufacturers, authorized representatives, importers and distributors, including the establishment of risk management and quality management systems and (vi) the obligation for manufacturers to appoint a person responsible for regulatory compliance with the task of ensuring that the conformity of the devices is appropriately checked, that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date and that post-market surveillance and reporting obligations are complied with.
- In addition, the IVDR also introduces for in vitro diagnostic devices a unique identification system (UDI), aimed at improving the identification and traceability of devices, consisting of a device identifier (UDI-DI) specific to a manufacturer and a device and production identifier (UDI-PI) that identifies the unit of device production.
- Lastly, in vitro diagnostic devices must be registered in the European medical device database “Eudamed,” intended to monitor their product life cycle and to improve the transparency and coordination of information.
