Regulation (EU) 2022/112 of the European Parliament and of the Council has been published in the Official Journal of the European Union. It amends Regulation (EU) 2017/746 with regard to the transitional provisions pertaining to certain in vitro diagnostic medical devices and the deferred application of the conditions for devices manufactured and used in-house by healthcare establishments.
In order to ensure an uninterrupted supply of these devices, the transitional periods provided for in Regulation (EU) 2017/746 are extended depending on the risk class of the device concerned, so that it is shorter for devices in a higher risk class and longer for devices in a lower risk class.
These provisions relate to devices that may be subject to Article 110 of the regulation which have a valid certificate under Directive 98/79/EC and devices that do not have a directive certificate and have to submit the device’s conformity assessment to a notified body, for the first time.
The length of the transition periods depends on the type of device: Class D devices and some Class C devices benefit from a transition period until May 2025 and 2026, while low-risk devices (Class B and A) would benefit from a transition period until May 2027.
The application date of Regulation (EU) 2017/746 is maintained at May 26, 2022 and devices not eligible for the transitional period have to comply by the aforementioned date in order to be placed on the market.
These rules enter into force on January 28, 2022.