Clinical evidence requirements according to the IVDR 2017/746: practical tools and references for underpinning clinical evidence of IVD-MDs.
in vitro diagnostic
2017/746 IVDR
analytical performance
clinical evidence
clinical performance
performance evaluation
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
27 06 2023
27 06 2023
Historique:
received:
09
12
2022
accepted:
27
02
2023
medline:
30
5
2023
pubmed:
16
3
2023
entrez:
15
3
2023
Statut:
epublish
Résumé
In May 2022, the European Regulation 2017/746 (IVDR) came into force. It changes the approach of
Identifiants
pubmed: 36919280
pii: cclm-2022-1252
doi: 10.1515/cclm-2022-1252
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1150-1157Informations de copyright
© 2023 the author(s), published by De Gruyter, Berlin/Boston.
Références
The European Parliament. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) [Internet]. OJ L; 2017. Available from: http://data.europa.eu/eli/reg/2017/746/oj/eng .
The European Parliament. Directive 98/79/EC of the european parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices [Internet]. OJ L; 1998. Available from: http://data.europa.eu/eli/dir/1998/79/oj/eng .
The European Parliament. Regulation (EU) 2022/112 of the european parliament and of the council of 25 January 2022 amending regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices (text with EEA relevance) [Internet]. OJ L; 2022. Available from: http://data.europa.eu/eli/reg/2022/112/oj/eng .
MedTech, Europe. Analysing the availability of IVDs in May 2022 [Internet - cited 2022 Aug 24]; 2022. Available from: https://www.medtecheurope.org/resource-library/medtech-europe-survey-report-analysing-the-availability-of-in-vitro-diagnostic-medical-devices-ivds-in-may-2022-when-the-new-eu-ivd-regulation-applies/ .
European Commission. New Approach Notified and Designated Organisations. [Internet - cited 2022 Aug 18]; 2022. Available from: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 .
Ries, F. Question parlementaire | Manque d’organismes notifiés à l’aube de la mise en application du règlement relatif aux dispositifs médicaux de diagnostic in vitro | P-001914/2022 | Parlement européen [Internet]; 2022. Available from: https://www.europarl.europa.eu/doceo/document/P-9-2022-001914_FR.html [Accessed 4 Jan 2023].
The Medical Device Coordination Group . Guidance - MDCG endorsed documents and other guidance [Internet - cited 2022 Aug 22]; 2022. Available from: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en .
The European Parliament. EUR-Lex - 32022R0112 - EN - EUR-Lex [Internet - cited 2023 Feb 4]; 2022. Available from: https://eur-lex.europa.eu/eli/reg/2022/112/oj/eng .
Cobbaert, C, Capoluongo, ED, Vanstapel, FJLA, Bossuyt, PMM, Bhattoa, HP, Nissen, PH, et al.. Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis. Clin Chem Lab Med 2022;60:33–43. https://doi.org/10.1515/cclm-2021-0975 .
doi: 10.1515/cclm-2021-0975
International Organization for Standardization. ISO 15189:2022 [Internet - cited 2023 Feb 4]. Available from: https://www.iso.org/fr/standard/76677.html .
The International Electrotechnical Commission. IEC 62304:2006+AMD1:2015 CSV | IEC Webstore | cyber security, smart city [Internet - cited 2023 Feb 4]. Available from: https://webstore.iec.ch/publication/22794 .
van Deutekom, HWM, Haitjema, S. Recommendations for IVDR compliant in-house software development in clinical practice: a how-to paper with three use cases. Clin Chem Lab Med 2022;60:982–8. https://doi.org/10.1515/cclm-2022-0278 .
doi: 10.1515/cclm-2022-0278
MedTech, Europe. IVD Regulation - Flowchart - Fact Sheets [Internet - cited 2022 Aug 22]; 2017. Available from: https://www.medtecheurope.org/resource-library/ivd-regulation-flowchart/ .
MedTech, Europe. Clinical Evidence Requirements for CE certification [Internet - cited 2022 Aug 22]; 2022. Available from: https://www.medtecheurope.org/resource-library/clinical-evidence-requirements-for-ce-certification-under-the-in-vitro-diagnostic-regulation-in-the-european-union/ .
Horvath, AR, Lord, SJ, StJohn, A, Sandberg, S, Cobbaert, CM, Lorenz, S, et al.. From biomarkers to medical tests: the changing landscape of test evaluation. Clin Chim Acta 2014;427:49–57. https://doi.org/10.1016/j.cca.2013.09.018 .
doi: 10.1016/j.cca.2013.09.018
Lesko, LJ, Zineh, I, Huang, SM. What is clinical utility and why should we care? Clin Pharmacol Ther 2010;88:729–33. https://doi.org/10.1038/clpt.2010.229 .
doi: 10.1038/clpt.2010.229
European commission. Public health : commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation [Internet - cited 2022 Aug 18]; 2021. Available from: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209 .
International Organization for Standardization. ISO 20916:2019 [Internet - cited 2023 Feb 4]. Available from: https://www.iso.org/standard/69455.html .
Lord, SJ, St John, A, Bossuyt, PM, Sandberg, S, Monaghan, PJ, O’Kane, M, et al.. Setting clinical performance specifications to develop and evaluate biomarkers for clinical use. Ann Clin Biochem 2019;56:527–35. https://doi.org/10.1177/0004563219842265 .
doi: 10.1177/0004563219842265
International Organization for Standardization. ISO 17511:2020 [Internet - cited 2023 Feb 15]. Available from: https://www.iso.org/fr/standard/69984.html
Leeflang, MMG, Allerberger, F. How to: evaluate a diagnostic test. Clin Microbiol Infect 2019;25:54–9. https://doi.org/10.1016/j.cmi.2018.06.011 .
doi: 10.1016/j.cmi.2018.06.011
Nishikawa-Pacher, A. Research questions with PICO: a universal mnemonic. Publications 2022;10:21. https://doi.org/10.3390/publications10030021 .
doi: 10.3390/publications10030021
Page, MJ, Moher, D, Bossuyt, PM, Boutron, I, Hoffmann, TC, Mulrow, CD, et al.. PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews. BMJ 2021;372:n160. https://doi.org/10.1136/bmj.n160 .
doi: 10.1136/bmj.n160
Page, MJ, McKenzie, JE, Bossuyt, PM, Boutron, I, Hoffmann, TC, Mulrow, CD, et al.. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71 .
doi: 10.1136/bmj.n71
Whiting, PF, Rutjes, AWS, Westwood, ME, Mallett, S, Deeks, JJ, Reitsma, JB, et al.. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med 2011;155:529–36. https://doi.org/10.7326/0003-4819-155-8-201110180-00009 .
doi: 10.7326/0003-4819-155-8-201110180-00009
Yang, B, Mallett, S, Takwoingi, Y, Davenport, CF, Hyde, CJ, Whiting, PF, et al.. QUADAS-C: a tool for assessing risk of bias in comparative diagnostic accuracy studies. Ann Intern Med 2021;174:1592–9. https://doi.org/10.7326/m21-2234 .
doi: 10.7326/m21-2234
Lee, J, Mulder, F, Leeflang, M, Wolff, R, Whiting, P, Bossuyt, PM. QUAPAS: an adaptation of the QUADAS-2 tool to assess prognostic accuracy studies. Ann Intern Med 2022;175:1010–8. https://doi.org/10.7326/m22-0276 .
doi: 10.7326/m22-0276
Sterne, JAC, Savović, J, Page, MJ, Elbers, RG, Blencowe, NS, Boutron, I, et al.. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898. https://doi.org/10.1136/bmj.l4898 .
doi: 10.1136/bmj.l4898
Sterne, JA, Hernán, MA, Reeves, BC, Savović, J, Berkman, ND, Viswanathan, M, et al.. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ 2016;355:i4919. https://doi.org/10.1136/bmj.i4919 .
doi: 10.1136/bmj.i4919
European commissions. Commission implementing regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with regulation (EU) 2017/746 of the european parliament and of the council (text with EEA relevance) [Internet]. OJ L; 2022. Available from: http://data.europa.eu/eli/reg_impl/2022/1107/oj/eng .
World Health organization. Performance Evaluation . Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control). 2020 [Internet - cited 2023 Jan 17]. Available from: https://extranet.who.int/pqweb/vitro-diagnostics/performance-evaluation .
Global Harmonization Task Force Study Group 5 . International Medical Device Regulators Forum. Clinical Safety/Performance [Internet - cited 2023 Jan 19]; 2012. Available from: https://www.imdrf.org/documents/ghtf-final-documents/ghtf-study-group-5-clinical-safetyperformance .
Martin Bland, J, Altman, DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;327:307–10. https://doi.org/10.1016/s0140-6736(86)90837-8 .
doi: 10.1016/s0140-6736(86)90837-8
Cohen, J. A coefficient of agreement for nominal scales. Educ Psychol Meas 1960;20:37–46. https://doi.org/10.1177/001316446002000104 .
doi: 10.1177/001316446002000104
Stergiou, GS, Alpert, B, Mieke, S, Asmar, R, Atkins, N, Eckert, S, et al.. A universal standard for the validation of blood pressure measuring devices: association for the advancement of medical instrumentation/European society of hypertension/international organization for standardization (AAMI/ESH/ISO) collaboration statement. Hypertens Dallas Tex . 2018;71:368–74, https://doi.org/10.1161/hypertensionaha.117.10237 .
doi: 10.1161/hypertensionaha.117.10237
Sammut-Powell, C, Reynard, C, Allen, J, McDermott, J, Braybrook, J, Parisi, R, et al.. Examining the effect of evaluation sample size on the sensitivity and specificity of COVID-19 diagnostic tests in practice: a simulation study. Diagn Prognostic Res 2022;6:12. https://doi.org/10.1186/s41512-021-00116-4 .
doi: 10.1186/s41512-021-00116-4
Hajian-Tilaki, K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inf 2014;48:193–204. https://doi.org/10.1016/j.jbi.2014.02.013 .
doi: 10.1016/j.jbi.2014.02.013
Fahie-Wilson, MN, Cobbaert, CM, Horvath, AR, Smith, TP. Interference by macroprolactin in assays for prolactin: will the in Vitro Diagnostics Regulation lead to a solution at last? Clin Chem Lab Med 2022;60:1350–5. https://doi.org/10.1515/cclm-2022-0460 .
doi: 10.1515/cclm-2022-0460