News Category: Regulatory news
The European Parliament and Council have adopted an amendment to the IVDR, which defers the dates of application for certain in vitro diagnostic medical devices (IVDs). This includes higher-risk IVDs requiring notified body certification and in-house devices manufactured and used in the same health institution. No change is proposed for CE-marked IVDs that do not require notified body certification (Class A IVDs) under the IVDR or for ‘new’ devices where the IVDR applies from 26 May 2022.
This amendment allows for a more progressive roll-out of requirements and aims to prevent potential disruption to supply of essential IVDs, due to the shortage in notified body capacity. While the proposed amendment to the IVDR is welcomed, the HPRA encourages our stakeholders to continue increasing their efforts with IVDR preparedness and implementation activities. IVDR requirements such as those related to post-market surveillance, market surveillance, vigilance and registration will continue to apply from 26 May 2022.