Official documents and guidance
On the EUR-Lex website, the IVDR is available in all the official languages of the EU.
After a request of the European Parliament and following alarms by different IVDR stakeholders, the European Commission has proposed amendments regarding transitional provisions. For in-house devices: Article 5.5b-i (except d) will apply from 2024, Article 5.5d will apply from 2028 (the GSPR in Annex I and Article 5.5a will still apply from 2022 according to the current proposal). For CE-IVDs: IVDR date of application remains 26 May 2022 (for new devices and class A non-sterile devices), the grace period for notified body-certified devices is prolonged with 1 year (to 2025), class D devices need to be CE marked under the IVDR by 2025, class C devices by 2026, class B devices by 2027. Note that this proposal still needs to be approved.
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.
Tutorial 1: Definitions, urgency, transition IVDD to IVDR;
Tutorial 2: IVDR structure, transition timeline;
Tutorial 3: Use of in-house devices, IVDR requirements for in-house devices;
Tutorial 4: Preparatory action 1: dedicated team, education;
Tutorial 5: Preparatory action 2: assay inventory;
Tutorial 6: Preparatory action 3: IVDR compliance;
Tutorial 7: Guidance, concerns, recommendations
Introduction (J.J.M. van Dongen);
IVDR – the perspective of the European Commission (O. Tkachenko);
IVDR – the perspective of the Dutch competent authority (S. Schoenmakers);
Implementing the IVDR in a diagnostic laboratory (I. Dombrink)
Publications (scientific journals)
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.
Lubbers BR, Schilhabel A, Cobbaert CM, Gonzalez D, Dombrink I, Brüggemann M, Bitter WM, van Dongen JJM. Hemasphere. 2021;5:e568
Report informing diagnostic labs on the scope, consequences and suggested preparation for the IVDR.
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).
Cobbaert C, Capoluongo ED, Vanstapel FJLA, Bossuyt PMM, Bhattoa HP, Nissen PH, Orth M, Streichert T, Young IS, Macintyre E, Fraser AG, Neumaier M. Clin Chem Lab Med. 2021. doi: 10.1515/cclm-2021-0975
Hoffmüller P, Brüggemann M, Eggermann T, Ghoreschi K, Haase D, Hofmann J, Hunfeld KP, Koch K, Meisel C, Michl P, Müller J, Müller C, Rabenau HF, Reinhardt D, Riemenschneider MJ, Sachs UJ, Sack U, Stenzinger A, Streichert T, von Neuhoff N, Weichert W, Weinstock C, Zimmermann S, Spitzenberger F; AWMF Ad hoc Commision In-vitro Diagnostic Medical Devices. Ger Med Sci. 2021;19:Doc08
Spitzenberger F, Patel J, Gebuhr I, Kruttwig K, Safi A, Meisel C. Ther Innov Regul Sci. 2021. doi: 10.1007/s43441-021-00323-7
Dombrink I, Lubbers BR, Simulescu L, Doeswijk R, Tkachenko O, Dequeker E, Fraser A, van Dongen JJM, Cobbaert C, Brüggemann M, Macintyre E. HemaSphere. 2022;6:e724
Conferences and meetings
Amsterdam, The Netherlands, 10-12 May 2022
Annual conference for regulatory professionals operating in Europe and other countries who want to comply with European regulatory policies (in particular IVDR and MDR).
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