Structure and content of the EU-IVDR: Current status and implications for pathology
Open accessAbstract
Background: Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for certain in vitro diagnostic medical devices (IVDs) and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December 2021. The combined use of CE-certified IVDs (CE-IVDs), in-house IVDs (IH-IVDs), and research use only (RUO) devices are a cornerstone of diagnostics in pathology departments and crucial for optimal patient care. The IVDR not only regulates the manufacture and placement on the market of industrially manufactured IVDs, but also imposes conditions on the manufacture and use of IH-IVDs for internal use by healthcare facilities. Objectives: Our work provides an overview of the background and structure of the IVDR and identifies core areas that need to be interpreted and fleshed out in the context of the legal framework as well as expert knowledge. Conclusions: The gaps and ambiguities in the IVDR crucially require the expertise of professional societies, alliances, and individual stakeholders to successfully facilitate the implementation and use of the IVDR in pathology departments and to avoid aberrant developments.
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Buffer systems, artificial saliva, and selected saliva/serum samples show that PDA-based biosensing platforms can achieve improved biomolecule immobilization, signal transduction, fluorescence/electrochemical/SERS detection, and salivary biomarker analysis.
“Buffer systems, artificial saliva, and selected saliva/serum samples show improved biomolecule immobilization, signal transduction, fluorescence/electrochemical/SERS detection, and salivary biomarker analysis.”
From Polydopamine-Based Biomaterials in Oral Medicine: Applications, Mechanisms, and Translational Challenges (2026) · cites this paper as [99]
The Performance evaluation section discusses validation of pathology assays, and the Risk management and safety evaluation section discusses safety assessments for in-house diagnostic devices. Neither addresses PDA-based biosensors or the claimed results in buffer, artificial saliva, or saliva/serum samples. Searches for PDA biosensing and salivary-biomarker detection found no relevant passage in our copy. (LLM, conf=0.78)
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Research works printed but not linked: 9
- [2]Bank PCD Jacobs LHJ Van Den Berg SA The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications Clin Chem Lab Med 2020 10.1515/cclm-2020-1384 33554568 · DOI
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- [19]Lubbers BR Schilhabel A Cobbaert CM The new EU regulation on in vitro diagnostic medical devices: implications and preparatory actions for diagnostic laboratories Hemasphere 2021 5 e568 10.1097/HS9.0000000000000568 33898932 PMC8061679 · DOI
- [22]Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen (RiLi-BÄK-2019) 26552920
- [23]Scheiblauer H Filomena A Nitsche A Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021 Euro Surveill 2021 26 44 2100441 10.2807/1560-7917.ES.2021.26.44.2100441 34738515 PMC8569926 · DOI
- [24]Spitzenberger F Patel J Gebuhr I Kruttwig K Safi A Meisel C Laboratory-developed tests: design of a regulatory strategy in compliance with the international state-of-the-art and the regulation (EU) 2017/746 (EU IVDR [in vitro diagnostic medical device regulation]) Ther Innov Regul Sci 2022 56 1 47 64 10.1007/s43441-021-00323-7 34291407 PMC8294224 · DOI
- [25]Stenzinger A Weichert W Impact of the novel in vitro diagnostic regulation (IVDR) of the European Union on pathology laboratories. What’s important? Pathologe 2020 41 129 133 10.1007/s00292-020-00867-9 33263810 · DOI
- [26]Strom SP Current practices and guidelines for clinical next-generation sequencing oncology testing Cancer Biol Med 2016 13 3 11 10.20892/j.issn.2095-3941.2016.0004 27144058 PMC4850126 · DOI
- [29]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 2021 59 1 101 106 10.1515/cclm-2020-0804 32692695 · DOI
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Yang, Z., Song, W., Lv, L., Zhai, S., Liu, Y., Cui, H., Li, X., Gao, F., & Chu, S. (2026) · International Journal of Nanomedicine · doi:10.2147/ijn.s611922
- Authors
- Kahles, A., Goldschmid, H., Volckmar, A.-L., Ploeger, C., Kazdal, D., Penzel, R., Budczies, J., Kempny, G., Kazmierczak, M., Flechtenmacher, C., Baretton, G., Weichert, W., Horst, D., Klauschen, F., Gassner, U. M., Brüggemann, M., Vogeser, M., Schirmacher, P., & Stenzinger, A.
- Affiliations
- University Hospital Heidelberg (DE)
- University Hospital Carl Gustav Carus (DE)
- Technical University of Munich (DE)
- Charité – Universitätsmedizin Berlin (DE)
- Pathologisches Institut (DE)
- University of Augsburg (DE)
- University Hospital Schleswig-Holstein (DE)
- Institut für Laboratoriumsmedizin (DE)
- Corresponding author
- Kahles, Andy
- Stenzinger, Albrecht
- ORCID
- Venue
- Die Pathologie
- Published
- 2023-02-03
- Volume
- 44
- Issue
- S2
- Pages
- 73-85
- ISSN
- 2731-7188 (ISSN-L)
- 2731-7196
- PMC
- PMC9896441
- OpenAlex
- W4319060531
- Cited by
- 27
- References
- 0
- Citations by year
- 2026: 6 · 2025: 11 · 2024: 7 · 2023: 3
- FWCI
- 1.06
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Die Pathologie (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- OPUS (Augsburg University) (submittedVersion, cc-by)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion, other-oa)
- Funders
- Universitätsklinikum Heidelberg
- Topics
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- in vitro diagnostic medical devices, CE marking, regulatory implementation, pathology department, transitional provisions
- MeSH terms
- Commerce, European Union, Health Facilities, Humans, Reagent Kits, Diagnostic
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