European In Vitro Diagnostic Regulation (EU IVDR) is a new Regulatory basis for placing IVDs in the European market. The EU IVDR Regulation is set to replace the EU’s current Directive on in vitro diagnostic medical devices (EU 98/79/EC). As a European regulation, it will be effective in all the EU Member States and the European Free Trade Association (EFTA) states without any need to be transferred into the law of respective States.
Mandated to be effective from May 26, 2022, the new EU IVDR is considered as a significant change to the Regulatory oversight of IVDs. Overview of the IVDR transition is as below –
Once fully implemented, the IVDR compliance rules ensure that almost all IVDs entering the European market are subject to the IVDR Notified Body (NB) review and the CE marking certification as a part of the IVD Approval Process. In this scenario, apart from aligning with the updated IVDR classification, there is an immediate requirement for manufacturers to effectively review the key technical documentation for successful IVD registration and CE marking. The IVDR requirements vary with the risk class of the IVD. In general, for the IVD Certification, manufacturers must perform:
As a proven Regulatory partner, Freyr assists manufacturers for compliant In Vitro Diagnostic Regulation and CE marking. Freyr can support in performing a systematic review of the scientific literature and aid in the planning and preparation of a PER for In Vitro Diagnostic Regulation compliance. Freyr has dedicated experts to support Post-market Surveillance (PMS), which is an integral part of the manufacturer’s quality management system along with Post-market Performance Follow-up (PMPF).