With just six notified bodies designated under the IVD Regulation, and amidst repeated warnings of insufficient auditing capacity, the EU could lose between three-quarters and over a half of its IVDs, a recent survey warns.

In a best-case scenario 61% of today’s IVDs will be certified by the 26 May 2022 IVD Regulation deadline, and in a worst-case scenario only 24% will be, a survey recently conducted by EU medtech industry association MedTech Europe found.

The conditions for this crisis situation have mainly arisen because, while just 8% of IVDs need a notified body certificate under the currently applicable IVD Directive, 78% will need notified body involvement under the IVDR. That is according to the organization’s latest estimates.

The biggest loss, it predicts, is likely to come from SMEs who make niche products in smaller volumes and who may be less able to endure loss of business, MedTech Europe says.

The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.

The European Commission has proposed a “progressive” roll-out of the new IVDR to prevent disruption in the supply of IVDs.

While the IVDR will fully apply on 26 May 2022, as expected, there will be a tiered system allowing many products a grace period before they have to be fully compliant with the regulation.

Under certain circumstances, as cited below, Class D higher risk IVDs, such as HIV or hepatitis tests, would have a transition period of three years, until May 2025, while class C IVDs, such as certain influenza tests, would not have to be compliant until May 2026, according to a proposal issued on 14 October. Lower risk IVDs, meanwhile, such as class B and A sterile devices, would not have to be fully compliant until five years later than the current deadline of May 2027.