ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European
AB, accrediting body
BRCA1/2, breast cancer genes 1 and 2
CA, competent authority
CAPA, corrective and preventive actions
CDx, companion diagnostics
CGP, comprehensive genomic profile
CRGA, clinically relevant genomic alterations
EEA, European economic area
EFLM, European Federation of Clinical Chemistry and Laboratory Medicine
EMA, European Medicines Agency
EU, European Union
European Regulation 2017/746 on In-Vitro-Diagnostic Devices
FMEA, failure-mode effects analysis
GA, genomic alterations
GDPR, General Data Protection Regulation
HI, health institution
HRD, homologous recombination deficiency
HRR, homologous recombination repair
ISO 15189:2012
ISO, International Organization for Standardization
IVDD, In-Vitro Diagnostic Device Directive
IVDR, In-Vitro Diagnostic Device Regulation
LDT, laboratory-developed test
MDCG, Medical Device Coordination Group
MSI, micro satellite instability
MU, measurement uncertainty
NB, notified body
NGS, next generation sequencing
NTRK, neurotrophic tyrosine receptor kinase
PARPi, poly (ADP-ribose) polymerase inhibitors
PRRC, person responsible for regulatory compliance
PT, proficiency testing
RUO, research use only
RiliBÄk, Richtlinie der Bundesärztekammer zur Qualitätssicherung Laboratoriums medizinischer Untersuchungen
SOP, standard operating procedure
TMB, tumor mutational burden
UDI, unique device identifier
VAF, variant allele frequency
iQC, internal quality control
laboratory-developed tests for in-house use
method validation
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:
28 03 2023
28 03 2023
Historique:
received:
12
01
2023
accepted:
15
01
2023
pubmed:
31
1
2023
medline:
3
3
2023
entrez:
30
1
2023
Statut:
epublish
Résumé
The EU
Identifiants
pubmed: 36716120
pii: cclm-2023-0045
doi: 10.1515/cclm-2023-0045
doi:
Substances chimiques
Reagent Kits, Diagnostic
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
608-626Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2023 Walter de Gruyter GmbH, Berlin/Boston.
Références
Casteret, AM. L’affaire du sang. 1992 , 2nd ed. Paris, France: La Découverte; 1992. ISBN/ISSN 978-2-7071-2115-8.
Greco, C. The Poly Implant Prothèse breast prostheses scandal: embodied risk and social suffering. Soc Sci Med 2015;147:150–7. https://doi.org/10.1016/j.socscimed.2015.10.068 .
doi: 10.1016/j.socscimed.2015.10.068
European Parliament and Council Regulation (EU) 2017/745 of 5 April 2017 on medical devices : Official Journal of the European Union; 2017, vol 117:1–175 pp. Available from: http://data.europa.eu/eli/reg/2017/745/oj [Accessed 3 Jun 2022].
European Parliament and Council Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices : Official Journal of the European Union; 2017, vol 117:176–332 pp. Available from: http://data.europa.eu/eli/reg/2017/746/oj [Accessed 5 Jul 2022].
European Commission. EUDAMED – European Database on Medical Devices ; 2020. Available from: https://ec.europa.eu/tools/eudamed/#/screen/home [Accessed 3 Jun 2022].
International Organization for Standardization . ISO 15189:2012 Medical laboratories – Requirements for quality and competence . Geneva, Switzerland. Available from: https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-3:v2:en [Accessed: 6 Jun 2022].
Cobbaert, C, Capoluongo, ED, Vanstapel, FJ, Bossuyt, PM, 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
European Parliament and Council Regulation (EU) 2022/112 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 : Official Journal of the European Union; 2022, vol 19:3–6 pp. Available from: http://data.europa.eu/eli/reg/2022/112/oj [Accessed 4 Dec 2022].
European Parliament and Council Regulation (EC) No 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/4 : Official Joural of the European Union; 2022, vol 396:1–849 pp. Available from: http://data.europa.eu/eli/reg/2006/1907/2022-05-01 [Accessed 4 Dec 2022].
Medical Device Coordination Group . MDCG 2022-14 MDCG Position Paper Transition to the MDR and IVDR. Notified body capacity and availability of medical devices and IVDs . Available from: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf [Accessed 2 Sep 2022].
Horgan, D, Plebani, M, Orth, M, Macintyre, E, Jackson, S, Lal, JA, et al.. The gaps between the new EU legislation on in vitro diagnostics and the on-the-ground reality. Clin Chem Lab Med 2022;61:224–33. https://doi.org/10.1515/cclm-2022-1051 .
doi: 10.1515/cclm-2022-1051
Vermeersch, P, Van Aelst, T, Dequeker, EM. 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 2020;59:101–6. https://doi.org/10.1515/cclm-2020-0804 .
doi: 10.1515/cclm-2020-0804
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;56:47–64. https://doi.org/10.1007/s43441-021-00323-7 .
doi: 10.1007/s43441-021-00323-7
Boursier, G, Vukasovic, I, Meško Brguljan, P, Lohmander, M, Ghita, I, Bernabeu Andreu, FA, et al.. Accreditation process in European countries – an EFLM survey. Clin Chem Lab Med 2016;54:545–51. https://doi.org/10.1515/cclm-2015-0780 .
doi: 10.1515/cclm-2015-0780
Thelen, MH, Vanstapel, FJ, Kroupis, C, Vukasovic, I, Boursier, G, Barrett, E, et al.. Flexible scope for ISO 15189 accreditation: a guidance prepared by the European federation of clinical chemistry and laboratory medicine (EFLM) working group accreditation and ISO/CEN standards (WG-A/ISO). Clin Chem Lab Med 2015;53:1173–80. https://doi.org/10.1515/cclm-2015-0257 .
doi: 10.1515/cclm-2015-0257
Bank, PC, Jacobs, LH, van den Berg, SA, van Deutekom, HW, Hamann, D, Molenkamp, R, et al.. 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;59:491–7. https://doi.org/10.1515/cclm-2020-1384 .
doi: 10.1515/cclm-2020-1384
Jacobs, L, Ruivenkamp, C, Bank, P, van Deutekom, H, Hamann, D, Molenkamp, R, et al.. Handvat gebruik lab-developed tests zoals beschreven in VERORDENING (EU) 2017/746 van 5 april 2017 betreffende medische hulpmiddelen voor in-vitrodiagnostiek . Available from: https://pathology.nl/wp-content/uploads/2020/07/Handvat_gebruik_LDT_IVDR_taskforce_vs1.0.pdf [Accessed 10 Jul 2022].
Barberis, M. In vitro diagnostic medical device regulation (IVDR): the end of laboratory developed tests (LDT)? Pathologica 2021;113:68–9. https://doi.org/10.32074/1591-951x-237 .
doi: 10.32074/1591-951x-237
Hoffmüller, Brüggemann, M, Eggermann, T, Ghoreschi, K, Haase, D, Hofmann, J, et al.. Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR). Ger Medical Sci 2021;19:1–9. https://doi.org/10.3205/000295 .
doi: 10.3205/000295
Orth, M, Averina, M, Chatzipanagiotou, S, Faure, G, Haushofer, A, Kusec, V, et al.. Opinion: redefining the role of the physician in laboratory medicine in the context of emerging technologies, personalised medicine and patient autonomy (‘4P medicine’). J Clin Pathol 2019;72:191–7. https://doi.org/10.1136/jclinpath-2017-204734 .
doi: 10.1136/jclinpath-2017-204734
Vogeser, M, Brüggemann, M. Complex analytical procedures in diagnostic laboratories and the IVDR. Clin Chem Lab Med 2021;59:457–8. https://doi.org/10.1515/cclm-2020-1775 .
doi: 10.1515/cclm-2020-1775
Vogeser, M, Bruggemann, M, Lennerz, J, Stenzinger, A, Gassner, UM. Laboratory-developed tests in the new European union 2017/746 regulation: opportunities and risks. Clin Chem 2022;68:40–2. https://doi.org/10.1093/clinchem/hvac048 .
doi: 10.1093/clinchem/hvac048
Medical Device Coordination Group . MDCG 2020-1 guidance on clinical evaluation (MDR)/performance evaluation (IVDR) of medical device software . Available from: https://ec.europa.eu/health/document/download/19d9e24f-2808-4e00-bfeb-75892047407d_en [Accessed 18 Jul 2022].
Medical Device Coordination Group . MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 . Available from: https://ec.europa.eu/health/document/download/59abcc81-fd32-4546-a340-24c8fad4e2ac_en?filename=mdcg_2022-10_en.pdf [Accessed 18 Jul 2022].
Medical Device Coordination Group . MDCG 2023-1 Guidance on the health institution exemption under article 5 (5) of the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 . Available from: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf [Accessed 12 Jan 2023].
Horvath, AR, Lord, SJ, StJohn, A, Sandberg, S, Cobbaeert, 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
Medical Device Coordination Group . MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110 (3) of the IVDR . Available from: https://ec.europa.eu/health/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf [Accessed 18 Jul 2022].
Medical Device Coordination Group . MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR . Available from: https://ec.europa.eu/health/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en [Accessed 18 Jul 2022].
Medical Device Coordination Group . MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 . Available from: https://ec.europa.eu/health/document/download/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf [Accessed 18 Jul 2022].
Panteghini, M, Ceriotti, F, Jones, G, Oosterhuis, W, Plebani, M, Sandberg, S. Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference. Clin Chem Lab Med 2017;55:1849–56. https://doi.org/10.1515/cclm-2017-0772 .
doi: 10.1515/cclm-2017-0772
Roelofsen-de Beer, R, Wielders, J, Boursier, G, Vodnik, T, Vanstapel, F, Huisman, W, et al.. Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation. Clin Chem Lab Med 2019;58:361–7. https://doi.org/10.1515/cclm-2019-1053 .
doi: 10.1515/cclm-2019-1053
Christenson, RH. Evidence-based laboratory medicine – a guide for critical evaluation. Ann Clin Biochem 2007;44:111–30. https://doi.org/10.1258/000456307780118127 .
doi: 10.1258/000456307780118127
Monaghan, PJ, Lord, SJ, StJohn, A, Sandberg, S, Cobbaert, CM, Lennartz, L, et al.. Biomarker development targeting unmet clinical needs. Clin Chim Acta 2016;460:211–9. https://doi.org/10.1016/j.cca.2016.06.037 .
doi: 10.1016/j.cca.2016.06.037
International Organization for Standardization . ISO 14971:2019(en) Medical devices – Application of risk management to medical devices . Geneva, Switzerland. Available from: https://www.iso.org/obp/ui/#iso:std:iso:14971:ed-3:v1:en [Accessed: 6 Jun 2022].
International Organization for Standardization . ISO/TR 24971:2020(en) Medical devices – Guidance on the application of ISO 14971 . Geneva, Switzerland. Available from: https://www.iso.org/obp/ui/#iso:std:iso:tr:24971:ed-2:v1:en [Accessed: 8 Jul 2022].
International Organization for Standardization . ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes . Geneva, Switzerland. Available from: https://www.iso.org/obp/ui/#iso:std:iso:13485:ed-3:v1:en [Accessed: 6 Jun 2022].
Thompson, M, Ellison, S, Wood, R. Harmonized guidelines for single laboratory validation of methods of analysis (IUPAC Technical Report). Pure Appl Chem 2002;74:835–55. https://doi.org/10.1351/pac200274050835 .
doi: 10.1351/pac200274050835
European Commission 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 (Text with EEA relevance) : Official Journal of the European Union; 2022, vol 178:3–56 pp. Available from: http://data.europa.eu/eli/reg_impl/2022/1107/oj [Accessed 21 Nov 2022].
International Organization for Standardization . ISO/TS 20914:2019 Medical laboratories – Practical guidance for the estimation of measurement uncertainty . Geneva, Switzerland. Available from: https://www.iso.org/standard/69445.html [Accessed 28 Oct 2022].
van Schrojenstein Lantman, MM, Can Çubukçu, H, Boursier, G, Panthegini, M, Bernabeu-Andreu, F, Milinkovic, N, et al.. An approach for determining allowable between reagent lot variation. Clin Chem Lab Med 2022;60:681–8. https://doi.org/10.1515/cclm-2022-0083 .
doi: 10.1515/cclm-2022-0083
Jun, GT, Ward, J, Morris, Z, Clarkson, J. Health care process modelling: which method when? Int J Qual Health Care 2009;21:214–24. https://doi.org/10.1093/intqhc/mzp016 .
doi: 10.1093/intqhc/mzp016
Bergman, B, Neuhauser, D, Provost, L. Five main processes in healthcare: a citizen perspective. BMJ Qual Saf 2011;20(1 Suppl):i41–2. https://doi.org/10.1136/bmjqs.2010.046409 .
doi: 10.1136/bmjqs.2010.046409
Choosing Wisely; 2012. Available from: https://www.choosingwisely.org/clinician-lists/#service=Lab [Accessed 15 Jun 2022].
Patra, KP, De Jesus, O. Sentinel event : StatPearls Publishing; 2021. PMID: 33232058. Available from: https://www.ncbi.nlm.nih.gov/books/NBK564388/ [Accessed 11 Jun 2022].
Kinns, H, Pitkin, S, Housley, D, Freedman, DB. Internal quality control: best practice. J Clin Pathol 2013;66:1027–32. https://doi.org/10.1136/jclinpath-2013-201661 .
doi: 10.1136/jclinpath-2013-201661
Çubukçu, HC, Vanstapel, F, Thelen, M, Bernabeu-Andreu, FA, van Schrojenstein Lantman, M, Brugnoni, D, et al.. Improving the laboratory result release process in the light of ISO 15189:2012 standard. Clin Chim Acta 2021;522:167–73. https://doi.org/10.1016/j.cca.2021.08.013 .
doi: 10.1016/j.cca.2021.08.013
NIH – National Library of Medicine – MedlinePlus. Comprehensive metabolic panel ; 1997. Available from: https://medlineplus.gov/ency/article/003468.htm [Accessed 15 Jun 2022].
NIH – National Library of Medicine – MedlinePlus. CBC blood test ; 1997. Available from: https://medlineplus.gov/ency/article/003642.htm [Accessed 15 Jun 2022].
Janssens, PMW. Lessen uit en over de analyse van bijzondere vochten. Ned Tijdschr Klin Chem Lab 2017;42:2–15.
Röcken, C, Mancke, H. Akkreditierung in der Pathologie: systematische Darstellung und Dokumentation der Tätigkeiten in der Pathologie. Pathologe 2010;31:268–78. https://doi.org/10.1007/s00292-009-1237-x .
doi: 10.1007/s00292-009-1237-x
Aleksakhina, SN, Imyanitov, EN. Cancer therapy guided by mutation tests: current status and perspectives. Int J Mol Sci 2021;22:10931. https://doi.org/10.3390/ijms222010931 .
doi: 10.3390/ijms222010931
Schwaederle, M, Zhao, M, Lee, J, Eggermont, A, Schilsky, RL, Mendelsohn, J, et al.. Impact of precision medicine in diverse cancers: a meta-analysis of phase II clinical trials. J Clin Oncol 2015;33:3817–25. https://doi.org/10.1200/jco.2015.61.5997 .
doi: 10.1200/jco.2015.61.5997
Delic, S, Rose, D, Kern, W, Nadarajah, N, Haferlach, C, Haferlach, T, et al.. Application of an NGS-based 28-gene panel in myeloproliferative neoplasms reveals distinct mutation patterns in essential thrombocythaemia, primary myelofibrosis and polycythaemia vera. Br J Haematol 2016;175:419–26. https://doi.org/10.1111/bjh.14269 .
doi: 10.1111/bjh.14269
Easwar, A, Siddon, AJ. Genetic landscape of myeloproliferative neoplasms with an emphasis on molecular diagnostic laboratory testing. Life 2021;11:1158. https://doi.org/10.3390/life11111158 .
doi: 10.3390/life11111158
Bühler, MM, Martin-Subero, JI, Pan-Hammarström, Q, Campo, E, Rosenquist, R. Towards precision medicine in lymphoid malignancies. J Intern Med 2022;292:221–42. https://doi.org/10.1111/joim.13423 .
doi: 10.1111/joim.13423
Eichhorst, B, Robak, T, Montserrat, E, Ghia, P, Niemann, CU, Kater, AP, et al.. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2021;32:23–33. https://doi.org/10.1016/j.annonc.2020.09.019 .
doi: 10.1016/j.annonc.2020.09.019
Wright, FC, De Vito, C, Langer, B, Hunter, A. Multidisciplinary cancer conferences: a systematic review and development of practice standards. Eur J Cancer 2007;43:1002–10. https://doi.org/10.1016/j.ejca.2007.01.025 .
doi: 10.1016/j.ejca.2007.01.025
van Duijl, TT, Ruhaak, LR, Smit, NPM, Pieterse, MM, Romijn, FPHTM, Dolezal, N, et al.. Development and provisional validation of a multiplex LC-MRM-MS. J Proteome Res 2021;20:5304–14. https://doi.org/10.1021/acs.jproteome.1c00532 .
doi: 10.1021/acs.jproteome.1c00532
World Medical Association . WMA declaration of Helsinki – Ethical principles for medical research involving human subjects. J Am Med Assoc 2013;310:2191–4. https://doi.org/10.1001/jama.2013.281053 .
doi: 10.1001/jama.2013.281053
European Parliament and Council Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance : Official Journal of the European Union; 2014, vol 158:1–76 pp. Available from: http://data.europa.eu/eli/reg/2014/536/oj [Accessed 4 Dec 2022].
Hermans, AMM, Maliepaard, M, Boon, WPC, Pasmooij, A. Impact of the new European Union in Vitro Diagnostics Regulation on the practice of hospital diagnostic laboratories. Expert Rev Mol Diagn 2022;22:583–90. https://doi.org/10.1080/14737159.2022.2087508 .
doi: 10.1080/14737159.2022.2087508
Maliepaard, M, Nibi, P, Nibi, G, Pasmooij, AMG. Evaluation of companion diagnostics in scientific advice and drug marketing authorization applications by the European medicines agency. Front Med 2022;9:893028. https://doi.org/10.3389/fmed.2022.893028 .
doi: 10.3389/fmed.2022.893028
Medical Device Coordination Group . Infographic Is your software a Medical Device? ; 2021. Available from: https://ec.europa.eu/health/document/download/b865d8e9-081a-4601-a91a-f120321c0491_en [Accessed 18 Jul 2022].
Naito, Y, Aburatani, H, Amano, T, Baba, E, Hayashid, T, Hayashida, T, et al.. Clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment (edition 2.1). Int J Clin Oncol 2021;26:233–83. https://doi.org/10.1007/s10147-020-01831-6 .
doi: 10.1007/s10147-020-01831-6
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
International Organization for Standardization . ISO/IEC 27002:2022(en) Information security, cybersecurity and privacy protection – Information security controls . Geneva, Switzerland. Available from: https://www.iso.org/obp/ui/#iso:std:iso-iec:27002:ed-3:v2:en [Accessed: 17 Jun 2022].
European Parliament and Council . Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) : Official Journal of the European Union; 2016, 119:1–88 pp. Available from: http://data.europa.eu/eli/reg/2016/679/oj [Accessed 4 Dec 2022].
European Commission . Proposal for a Regulation laying down harmonized rules on artificial intelligence (Artificial Intelligence Act) and amending certain union legislative acts ; 2021. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021PC0206&from=EN [Accessed 4 Dec 2022].
International Organization for Standardization . ISO/IEC JTC 1/SC 40/WG 1 Governance of Information Technology . Geneva, Switzerland; 2020. Available from: https://committee.iso.org/sites/jtc1sc40/home/projects/wg-1/published-wg1.html#:∼:text=ISO%2FIEC%20JTC%201%2FSC%2040%2FWG%201%20Governance%20of%20Information,organization%2C%20stakeholders%20and%20information%20technology.%2014%20November%202020 [Accessed: 15 Jun 2022].
International Organization for Standardization . IEC 62304:2006 – Medical device software – Software life cycle processes . Available from: https://www.iso.org/standard/38421.html .
Medical Device Coordination Group . Guidance – MDCG endorsed documents and other guidance; 2018. Available from: https://ec.europa.eu/health/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en [Accessed 18 Jul 2022].
European Parliament and Council Directive 2014/24/EU of 26 February 2014 on public procurement and repealing Directive 2004/18/EC : Official Journal of the European Union; 2014, vol 94:1–206 pp. Available from: http://data.europa.eu/eli/dir/2014/24/2022-01-01 [Accessed 4 Dec 2022].
European Council , Council regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty : Official Journal of the European Union; 2003, vol 1:1–25 pp. Available from: http://data.europa.eu/eli/reg/2003/1/oj [Accessed 4 Dec 2022].
International Organization for Standardization . ISO 15189:2022 Medical laboratories — Requirements for quality and competence . Geneva, Switzerland; 2022. Available from: https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-4:v1:en [Accessed: 28 Dec 2022].
European Federation of Clinical Chemistry and Laboratory Medicine. Working Group : Accreditation and ISO/CEN standards – Educational Resources ; 2014. Available from: https://www.eflm.eu/site/page/a/1146 [Accessed 20 Nov 2022].
Medical Device Coordination Group . MDCG 2020-16 Rev.1 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 . Available from: https://health.ec.europa.eu/system/files/2022-01/md_mdcg_2020_guidance_classification_ivd-md_en.pdf [Accessed 4 Dec 2022].