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Useful resources

Many diagnostic laboratories/health institutions have started preparations for the IVDR. To make this process efficient, it is crucial to have a basic understanding of the IVDR and to gain insight into the consequences of the requirements of this regulation. Many resources are available that provide general or specific information on this topic.

Official documents and guidance

On the EUR-Lex website, the IVDR is available in all the official languages of the EU.
Guidance document in preparation can be found under “MDCG work in progress – Ongoing guidance documents”. Most published guidance concerns the MDR; relevant published IVDR guidance includes the Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, published in Nov 2020. Guidance on conditions for in-house devices is in preparation and is expected in Q3-Q4 2021.

Publications

Vermeersch P, Van Aelst T, Dequeker EMC. Clin Chem Lab Med. 2020;59:101-106
Analysis of assay portfolio (CE-IVDs, modified/off-label CE-IVDs, RUOs, LDTs) and number of test results per assay by a large university hospital.
Bank PCD, Jacobs LHJ, van den Berg SAA, van Deutekom HWM, Hamann D, Molenkamp R, Ruivenkamp CAL, Swen JJ, Tops BBJ, Wamelink MMC, Wessels E, Oosterhuis WP. Clin Chem Lab Med. 2021;59:491–497
Opinion paper of the Dutch Task Force IVDR on interpretation of IVDR Art. 5(5) requirements and comparison of IVDR Annex I and ISO 15189 (a very useful cross-reference table is included in the supplementary material).

Conferences and meetings

Leiden, The Netherlands, 11-12 November 2021
The ESLHO Symposium 2021 will start with a half-day workshop on the IVDR for diagnostic laboratories. This workshop will provide the latest updates on the implementation of the IVDR. The focus will be on several aspects that are relevant in the final year before the date of application, such as guidance on drafting the documentation required for in vitro diagnostic tests, what to expect from national competent authorities, and opportunities for collaboration between diagnostic laboratories and industry.
Online meeting, 10-12 May 2021
Annual conference for regulatory professionals operating in Europe and other countries who want to comply with European regulatory policies (in particular IVDR and MDR).