The European Commission’s Medical Device Coordination Group (MDCG) recently published its guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.
This document (which is thankfully similar to earlier drafts) explains how IVDs should be classified in order to be placed on the market in the EU. The classification of a device drives the technical dossier and supporting evidence.
This is welcome, but really should have been published in early 2019 rather than in the final months of 2020. MedTech Europe has previously stated that in order to achieve the May 2022 implementation deadline, technical dossiers should be finalised in early 2021 meaning any manufacturer that needs to gather and analyse evidence is probably already out of time. In effect, most manufacturers, in the absence of guidance up until now, were compelled to rely on drafts and other documents (such as the International Medical Device Regulators Forum) to speculate on the correct classification of their IVD in order to gather supporting data.
The IVDR set out four classes (A-D), from lowest- to highest-risk, into which IVDs will be placed. The guidance provides that the intended purpose of an IVD is key to its classification and this should be clearly set out by the manufacturer in the technical documentation and instructions for use (IFU). Alongside intended purpose, the inherent risks of diagnostics are also relevant to the determination.
The guidance provides information in relation to seven rules (set out in Annex VIII to the IVDR) for determining the classification and also examples of diagnostics under each rule.
It does also provide some useful commentary about genetic testing, although inevitably, this is likely to change as the technology develops. The IVDR provides little if any detail on these types of products and some specific guidance on this growing area is much needed.