**Questions? [[Contact us!]]** # Introduction **Purpose and scope** The [In Vitro Diagnostic Medical Device Regulation](https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0112) establishes regulations for the introduction to the market, availability, or deployment of in vitro diagnostic medical devices intended for human use, as well as the accessories associated with such devices, within the European Union. Additionally, it extends to encompass performance studies conducted within the Union concerning these [[In vitro diagnostic medical devices]] and their related accessories. The IVDR replaced the existing *in vitro* diagnostic medical devices Directive (98/79/EC) (IVDD). **Who will be affected?** Manufactprs of IVD need to comply with the Regulation. The regulation does **not** apply to: - Products intended for general laboratory use or labeled as "research-use only" products, except when the manufacturer explicitly intends them for in vitro diagnostic testing due to their characteristics. - Products used for invasive sampling or those directly applied to the human body to collect specimens. - Internationally certified reference materials. - Materials utilized for external quality assessment programs. **Legislative status and transition period** On 25 January 2022, the regulation was published in the Official Journal of the European Union, making law the amendment to Regulation (EU) 2017/746 (IVDR). **New Transitional period IVDR** The In Vitro Diagnostic Medical Devices Regulation (IVDR) continues to be in full effect since May 26, 2022. However, the transitional period for obtaining certificates and introducing in vitro diagnostic devices (IVDs) to the market has been extended. The duration of these extensions depends on whether an IVD has a certificate under the previous In Vitro Diagnostic Devices Directive (IVDD) and/or if they require certification under the IVDR. The deadlines for health institutions to meet their new exemption requirements have also been extended accordingly. Depending on the IVDR risk class that would apply under the IVDR, extended transition periods may apply **for devices that did not require notified body involvement under the IVDD and for which the declaration of conformity was drawn up before May 26, 2022**: - Class A sterile and class B devices may continue to be placed on the market or put into service under the IVDD until May 26, 2027. - Class C devices may continue to be placed on the market or put into service under the IVDD until May 26, 2026. - Class D devices may continue to be placed on the market or put into service under the IVDD until May 26, 2025. Class A devices not requiring notified body involvement under the IVDR need to be complianed to the IVDR as of May 26, 2022. Manufacturers who are eligible for and choose to utilize the extended transition period are generally restricted from making significant alterations to the design or intended purpose of their devices. This restriction can pose particular challenges for manufacturers of software devices (e.g. AI). That means they already have to be complianed. # Definitions - [[Medical device]] - [[In vitro diagnostic medical devices]] - [[Unique Device Identifier (UDI)]] - [[Performance evaluation]] - [[Scientific Validity]] ## Classification of IVD ![[IVDR risicoclassificering (1).png]] **What are the differences between the [[MDR]] and the IVDR?** ![[MDR-IVDR Differences.png]]