IVDR (In Vitro Diagnostic Regulation)
The IVDR (Regulation (EU) 2017/746) is the European regulation on in vitro diagnostic medical devices, applicable since May 2022, replacing the former Directive 98/79/EC. It introduces a risk-based classification system with four classes (A to D) and imposes stricter requirements for clinical performance evaluation, technical documentation, and post-market surveillance. Like the EU MDR, it requires the provision of instructions for use in the official languages of target markets.
IVD manufacturers face particular requirements in IFU translation, as the instructions for use frequently describe complex diagnostic procedures and performance data that demand a high level of technical accuracy in translation.
Frequently Asked Questions
How does the IVDR differ from the EU MDR regarding IFU requirements?+
The IVDR contains specific requirements for IVD products, including particular information about specimen materials, performance characteristics, and laboratory conditions in the instructions for use. The new classification system (Classes A to D) means that significantly more IVDs require conformity assessment by a Notified Body, which also affects translation processes.