Is the IVD Regulation Framework ready for Class D Devices?

Under the IVD Regulation (EU) 2017/746 (‘IVDR’), Class D devices rely on a complex conformity assessment infrastructure involving not only a notified body but also an EU reference laboratory, the uploading of specific information to the EUDAMED database and – for novel devices in the absence of common specifications – additional assessment by an Expert Panel.

Moreover, the EU’s implementation of the IVDR has ground to a halt in the wake of the COVID-19 outbreak. The status of this transition, and the challenges it poses to all players in the IVD sector, has been discussed in a MedTech Europe position paper published in July 2020.

With the below paper, MedTech Europe aims to identify and raise awareness of those devices that are currently self-declared under IVD Directive and will become Class D under the IVDR. These devices are especially vulnerable to the IVDR transition period, because they cannot benefit from the so-called “grace period” that extends to 27 May 2024.2 For the purpose of this paper, these devices are referred to as ‘high-risk devices’. The full range of Class D infrastructure is needed well in advance of the date of application so that these IVDs can complete their IVDR certification before 26 May 2022. These include devices which are of critical importance to healthcare systems, e.g., because they are needed to screen the European blood supply, check cells and organs for transplantation or manage infectious disease outbreaks such as COVID-19 (SARS-CoV-2).

While it already takes around 12 months today to complete a dossier and certify a high-risk device under the IVD Directive, it is reasonable to assume this process will take much longer under the IVDR, given that it is new and much more complex. These high-risk devices (Class D without grace period) will need to have successfully completed their IVDR certification in just over a year and a half from now. Therefore, they heavily depend on timely availability of the full IVDR regulatory infrastructure. However, the specific Class D conformity assessment infrastructure is limited or missing.

From a public health perspective, it is critical that high-risk tests remain seamlessly available to European healthcare systems, without the need to rely on national or European derogations (ref. IVDR Article 54), or for Europe’s laboratories to address gaps in supply by creating in-house assays (ref. IVDR Article 5(5)).

MedTech Europe therefore asks for an urgent discussion to take place with the relevant parties, including the European Commission, National Competent Authorities and interested stakeholders in order to identify actions to smoothly transition these devices to the IVDR and safeguard continued access to these high-risk IVD devices.