Do you use laboratory-developed tests (LDTs)? If so, new regulations in the European Union may change the way you operate. In the EU, in vitro diagnostic devices (IVDs) must now begin to comply with new regulations that considerably raise the bar for compliance, both for IVD manufacturers and for laboratories relying on LDTs. Many laboratories face an additional challenge in that their own compliance track overlaps that of their manufacturers – labs need their LDT manufacturers to cross the finish line in good time to win their own compliance race. So, when it was introduced in 2017, the In Vitro Diagnostic Regulation (IVDR) challenge – with a compliance deadline of 2022 – always looked like it would be a difficult course to run. But worse was to come; for many EU laboratories and manufacturers, crossing the finish line by 2022 was made impossible by the unprecedented impact of the COVID-19 pandemic (1) – and some did not realize early enough that their LDTs fell within the scope of the IVDR (2,3). That’s why, for a significant part of the industry, racing to meet the 2022 deadline was just not possible – and this risked supply continuity for critical IVDs and LDTs.
Accordingly, in January 2022 the EU extended transitional provisions for IVDR compliance; laboratories now have an additional two years to bring their in-house assays or LDTs up to speed, whereas IVD manufacturers may benefit from up to five additional years (1,4). Though this helps many players catch their breath, it is not a signal to relax – or to slow down. The new requirements have not gone away, nor have their time and resource implications – such as the need to upgrade and maintain quality management systems and product design history files. Therefore, we must use the extended transition period efficiently, intensify our efforts, and commit the necessary resources to this endeavor.
In particular, it is critical for IVD end-users to know as soon as possible which products are intended to be IVDR-compliant. Note that it is each lab’s responsibility to ensure its assays comply with IVDR, a task that varies significantly in difficulty depending on whether the lab uses an IVD assay according to its intended purpose or seeks to validate an LDT. For IVD manufacturers, the marathon will be longer still; manufacturers have many more regulations to implement, not least due to additional clinical evidence and post-market surveillance requirements.
Clearly, there are costs associated with running the IVDR compliance race. Equally, though, participants can expect significant long-term benefits on the other side of the finish line. Consider, for example, the pre-IVDR situation for LDTs with quality requirements that vary significantly. With more stringent demands on IVD manufacturers, it makes sense to also demand enhanced oversight of LDTs – which, after all, carry the same kinds of risk and benefits for patients as commercial IVDs.
At the same time, IVD manufacturers should appreciate that IVDR compliance will improve product quality and thereby contribute to growing product demand as clinicians opt for approved (and improved) IVDs to support their treatment decisions. Finally, IVDR is likely to improve the overall quality and transparency of healthcare by raising the standards of all diagnostic tests and medical devices – a win-win end to the compliance race.
In brief, although IVDR is undoubtedly challenging to implement, we should remember that these new regulatory standards -- by contributing to a robust, consistent regulatory framework that applies to all IVD assays – will help improve both diagnostic efficacy and patient safety. Furthermore, as IVDR benefits become more broadly recognized over the coming years, this improved environment for patient diagnostics and safety is likely to spread globally (5). In other words, the race to meet new compliance standards is underway, and those who take immediate action to reach the finish line will enjoy the rewards of an improved and more streamlined testing environment.
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References
- European Commission, “Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation” (2021). Available at: https://bit.ly/3vENHzc.
- BR Lubbers et al., “The new EU regulation on in vitro diagnostic medical devices: implications and preparatory actions for diagnostic laboratories,” Hemasphere, 5, e568 (2021). PMID: 33898932.
- P Vermeersch et al., “The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care,” Clin Chem Lab Med, 59, 101 (2020). PMID: 32692695.
- European Commission, “Questions and answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation” (2021). Available at: https://bit.ly/3MMkR5Q.
- SA Robinson et al., “The changing regulatory landscape for laboratory developed tests” (2021). Available at: https://bit.ly/3FbqWWC.
