The date of application for Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) is approaching quickly. As of May 26, 2022, all manufacturers of IVD medical devices will have to fully comply to the new provisions unless a valid CE certificate issued under IVD Directive (IVDD) is available. The latter scenario will be applicable only for a very limited number of manufacturers.
The IVDR brings much stricter provisions in many aspects, but one of the most critical parts certainly is the performance evaluation with enhanced clinical data requirements. This appears especially relevant because most IVD medical devices will see a more stringent classification under the new regulatory regime where additional efforts may be needed to generate the necessary data.
The International Standardization Organization (ISO) has published standard ISO 20916 “In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice” in 2019. IVD medical device manufacturers should carefully review the performance evaluation process requirements and also take ISO 20916 into consideration in this context.