The purpose of this communication is to provide an overview of the European Regulation (EU) 2024/1860 of 13 June 2024, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed (European Database on Medical Devices), information obligation in case of interruption of supply, and the transitional provisions for certain in vitro diagnostic medical devices (IVDs).
One of the goals of Regulation (EU) 2024/1860 is to maintain patients’ access to a wide range of IVDs while ensuring a smooth transition to the new regulatory framework and to allow enough time for the certification process.
When it comes to the IVDR, the main feature of this amending regulation was providing an extension of the IVDR transitional period per risk class for IVDs meeting certain conditions. Most devices with certificates or declarations of conformity issued under the Directives may continue to be placed on the market after the respective dates of application of the Regulations (MDR/IVDR) until the end of the relevant transition period. Therefore, devices that are compliant with the previously applicable Directives and devices that are compliant with the current Regulations coexist and may be placed or made available simultaneously on the EU market ".
Which IVDs are in scope of this extension?
No transition period applies to IVDs that do not require the involvement of a notified body under the IVDR (i.e. class A non-sterile IVDs). Similarly, all 'new' IVDS, ie devices not previously covered by a certificate or DoC issued under the IVDD, cannot benefit from the extended IVDR transitional provisions.