Regulation (EU) 2017/746 – also known as IVDR (In Vitro Devices Regulation) has been adopted on the 5th April 2017 and will replace the IVDD (In Vitro Devices Directive). There is a transition period of 5 years making the regulation fully applicable in May 2022. There are massive changes compared to the IVDD confronting manufacturers with numerous challenges.
For instance, there are amended and new classification rules and risk classes. An estimated 80% of producers will find their products grouped in higher risk classes under the IVDR thus needing a Notified Body to remain in compliance. There will be an extended version of the Essential Requirements, now called the General Safety and Performance Principles or Requirements (GSPR). Also, the provisions for performance evaluation have been revised. The corresponding documents will be subject to enhanced scrutiny.
Further details can be found here.
As the transition period continues and guidance documents will be published, mdi Europa will remain at your side and guide you through.