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.
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). 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. This proposal has been approved by the European Parliament in December 2021.
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.
Other guidance documents
This page includes public statements of this task force and links to useful IVDR guidance documents of the AWMF (translated into English).
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)
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.
Report informing diagnostic labs on the scope, consequences and suggested preparation for the IVDR.
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).
The authors explain in detail that quality management under ISO 15189 is an appropriate and efficient way to fulfil the IVDR requirements for in-house devices.
Perspective summarizing the EHA-IVDR session of the EHA2022 Congress, in which laboratory professionals from 3 different EU countries shared their experiences with local implementation of the IVDR. Messages to different stakeholders are included at the end of the publication, aimed at supporting further IVDR implementation.
Results of a survey on current IVD use and preparedness for the IVDR sent out to diagnostic labs of all disciplines (Jul-Oct 2021).
Report summarizing IVDR requirements for manufacturers, including clinical evidence and post-market surveillance, and exploring different scenarios related to innovation, IP and collaboration between diagnostic labs and manufacturers that might occur under the IVDR, on the basis of different categories of IVDs (i.e. low to very high complexity CE-IVDs and IH-IVDs).
The November 2021 update of this Q&A document is also available via this link.
Conferences and meetings
Annual conference for regulatory professionals operating in Europe and other countries who want to comply with European regulatory policies (in particular IVDR and MDR).
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.
The laboratory test costing tool was developed by the WHO "to help laboratories evaluate the cost of a test, justify this cost and assist in producing pricelists for laboratory tests". It can also be useful for evaluation of the cost-efficiency of in-house devices when deciding whether or not to continue offering certain (infrequently used) tests under the IVDR. The user manual can be downloaded from https://www.euro.who.int/en/health-topics/Health-systems/laboratory-services/publications/laboratory-test-costing-tool-user-manual-2019.