The upcoming In Vitro Diagnostics Regulation (IVDR) presents laboratories involved in the diagnostic journey of patients across Europe with the task of adapting their practices in a substantial way. Time is ticking away toward the 26th of May 2022 when IVDR fully applies to the EU 27 countries, and countries with which it has mutual regulatory agreements namely; Lichtenstein Norway and Switzerland. Collectively these countries are known as the Union.
In vitro diagnostic medical devices are performed for one or several of the following purposes: to determine the compatibility of treatment, predicting treatment response or reactions, define or monitor therapeutic measures1. In order to accomplish these purposes, labs use either CE IVD tests or laboratory developed tests (LDTs). Within the Union, practices vary considerably as to which type of tests are used, but in many countries, there is significant reliance on the use of in-house testing2.
Although the IVDR has described provisions for in-house exemptions in article 5, there is still great uncertainty regarding its interpretation. Some of the terms raised as unclear include:
- An LDT can only be used on a ‘non-industrial scale’
- Target patient groups’ specific needs
- Prohibition on transfer of devices to another legal entity
- Appropriate level of performance by an equivalent device available on the market
However, understanding these exemptions is key, because current practices across the Union rely heavily on the use of LDTs3. The upcoming IVDR report examines these and other issues crucial to IVDR compliance (e.g. Notified Body capacity) in more depth and provides several pragmatic approaches for interpretation.
Ultimately, the infrastructure provided by DXRX-The Diagnostic Network® will help channel dynamic collaborations among laboratories and multidisciplinary entities involved in the diagnostic process of patients across the Union. This infrastructure provides opportunity to address issues at three crucial levels in the road to compliance:
- Clarity, by providing understanding as to what do some elements of the regulation actually mean
- Quality as the overriding metric, by providing evidence of quality across the Union
- Unity by providing a forum where patients, labs, and relevant stakeholders’ voices are hear regarding their concerns
For more information on IVDR collaboration opportunities, register for the latest Diaceutics IVDR Report here
References
- L_2017117EN.01017601.xml (europa.eu)
- Vermeersch P, Van Aelst T, Dequeker EMC. 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. 2020 Jul 21:/j/cclm.ahead-of-print/cclm-2020-0804/cclm-2020-0804.xml. doi: 10.1515/cclm-2020-0804. Epub ahead of print. PMID: 32692695.
- Laboratories self-report through DXRX platform
