Reference, calibration and referral laboratories - a look at current European provisions and beyond.
European Union Reference Laboratory
National Reference Laboratory
calibration laboratory
reference laboratory
referral laboratory
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:
14 Oct 2024
14 Oct 2024
Historique:
received:
10
09
2024
accepted:
23
09
2024
medline:
11
10
2024
pubmed:
11
10
2024
entrez:
10
10
2024
Statut:
aheadofprint
Résumé
European Union (EU) regulations on
Identifiants
pubmed: 39389923
pii: cclm-2024-1066
doi: 10.1515/cclm-2024-1066
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 Walter de Gruyter GmbH, Berlin/Boston.
Références
European Parliament and Council . 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). http://data.europa.eu/eli/reg/2017/746/oj [Accessed 04 Sep 2024].
European Parliament and Council . Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. http://data.europa.eu/eli/reg/2022/2371/oj [Accessed 04 Sep 2024].
European Parliament and Council . Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community. http://data.europa.eu/eli/dec/1998/2119/oj [Accessed 04 Sep 2024].
European Parliament and Council . Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC. http://data.europa.eu/eli/dec/2013/1082/oj [Accessed 04 Sep 2024].
European Centre for Disease Prevention and Control (ECDC) . Disease and laboratory networks. https://www.ecdc.europa.eu/en/about-ecdc/what-we-do/partners-and-networks/disease-and-laboratory-networks [Accessed 04 Sep 2024].
European Parliament and Council . Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (Text with EEA relevance). http://data.europa.eu/eli/reg/2017/625/oj [Accessed 04 Sep 2024].
European Commission . European union reference laboratories for animal health. Food and Feed, and Plant Health . https://food.ec.europa.eu/horizontal-topics/european-union-reference-laboratories_en [Accessed 04 Sep 2024].
European Commission . Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713 [Accessed 04 Sep 2024].
Biomedical Alliance in Europe . Statement: Urgent action needed to prevent widespread shortage of diagnostic tests. https://www.biomedeurope.org/images/news/2024/Statement_prevention_shortage_IVDs_final_16.01.pdf [Accessed 04 Sep 2024].
Medical Devices Coordination Group (MDCG) . Guidance on classification rules for in vitro diagnostic medical devices under regulation (EU) 2017/746. https://health.ec.europa.eu/system/files/2023-02/md_mdcg_2020_guidance_classification_ivd-md_en.pdf [Accessed 04 Sep 2024].
The Borderline and Classification Working Group (BCWG) . Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf [Accessed 04 Sep 2024].
European Commission . Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0944 [Accessed 04 Sep 2024].
ISO/IEC 17025:2017 . General requirements for the competence of testing and calibration laboratories . Geneva, Switzerland: International Organization for Standardization (ISO); 2017.
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 of the European Parliament and of the Council (Text with EEA relevance). http://data.europa.eu/eli/reg_impl/2022/1107/oj [Accessed 04 Sep 2024].
Bretthauer, M, Gerke, S, Hassan, C, Ahmad, OF, Mori, Y. The new European medical device regulation: Balancing innovation and patient safety. Ann Intern Med 2023;176:844–8. https://doi.org/10.7326/m23-0454 .
doi: 10.7326/m23-0454
Lubbers, BR, Schilhabel, A, Cobbaert, CM, Gonzalez, D, Dombrink, I, Brüggemann, M, et al.. The new EU regulation on in vitro diagnostic medical devices: Implications and preparatory actions for diagnostic laboratories. Hemasphere 2021;5:e568. https://doi.org/10.1097/hs9.0000000000000568 .
doi: 10.1097/hs9.0000000000000568
European Parliament and Council . Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (Text with EEA relevance). http://data.europa.eu/eli/reg/2024/1860/oj [Accessed 04 Sep 2024].
Covington & Burling LLP . European commission proposes to extend transitional periods for in-vitro-diagnostic medical devices. www.insideeulifesciences.com/2024/01/25/european-commission-proposes-to-extend-transitional-periods-for-in-vitro-diagnostic-medical-devices/ [Accessed 04 Sep 2024].
European Commission . Commission Implementing Regulation (EU) 2024/892 of 22 March 2024 designating European Union reference laboratories for certain specific areas of public health. http://data.europa.eu/eli/reg_impl/2024/892/oj [Accessed 04 Sep 2024].
European Commission . EU Reference Laboratories for public health. https://health.ec.europa.eu/health-security-and-infectious-diseases/surveillance-and-early-warning/eu-reference-laboratories-public-health_en [Accessed 04 Sep 2024].
European Parliament and Council . Regulation (EU) 2021/522 of the European parliament and of the Council of 24 March 2021 establishing a programme for the union’s action in the field of health (‘EU4Health programme’) for the period 2021-2027, and repealing regulation (EU) No 282/2014 (text with EEA relevance). http://data.europa.eu/eli/reg/2021/522/oj [Accessed 04 Sep 2024].
European Commission . Call for applications for the designation of an EU reference laboratory for public health in the field of food- and water- borne bacteria. https://health.ec.europa.eu/document/download/79f4172a-ba0b-426a-a672-6cd9de5e9c5c_en?filename=security_2024-eurl-call_fwb-bacteria_call_en.pdf [Accessed 04 Sep 2024].
Robert Koch Institut . National reference centers and consultant laboratories. https://www.rki.de/EN/Content/infections/Diagnostics/NatRefCentresConsultantLab/natRefCentresConsultantLab_node.html [Accessed 04 Sep 2024].
Institut Pasteur . Centres Nationaux de Référence. https://www.pasteur.fr/fr/sante-publique/CNR/les-cnr [Accessed 04 Sep 2024].
UK Health Security Agency . Specialist and reference microbiology: laboratory tests and services. https://www.gov.uk/guidance/specialist-and-reference-microbiology-laboratory-tests-and-services [Accessed 04 Sep 2024].
Austrian Agency for Health and Food Safety . National reference centres & laboratories. https://www.ages.at/en/ages/reference-centres-laboratories [Accessed 04 Sep 2024].
The infectious diseases toolkit. https://www.infectious-diseases-toolkit.org/national-resources/ [Accessed 04 Sep 2024].
European Centre for Disease Prevention and Control (ECDC) . Core functions of microbiology reference laboratories for communicable diseases . Stockholm: ECDC; 2010. https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Publications/1006_TER_Core_functions_of_reference_labs.pdf [Accessed 04 Sep 2024].
Albiger, B, Revez, J, Leitmeyer, KC, Struelens, MJ. Networking of public health microbiology laboratories bolsters europe’s defenses against infectious diseases. Front Public Health 2018;6:46. https://doi.org/10.3389/fpubh.2018.00046 .
doi: 10.3389/fpubh.2018.00046
European Centre for Disease Prevention and Control . ECDC public health microbiology strategy 2018-2022 . Stockholm: ECDC; 2018. https://www.ecdc.europa.eu/sites/default/files/documents/ECDC-public-health-microbiology-strategy-2018-2022.pdf [Accessed 04 Sep 2024].
European Commission . Surveillance and early warning. https://health.ec.europa.eu/health-security-and-infectious-diseases/surveillance-and-early-warning_en [Accessed 04 Sep 2024].
European Commission . Commission Implementing Decision (EU) 2018/945 of 22 June 2018 on the communicable diseases and related special health issues to be covered by epidemiological surveillance as well as relevant case definitions. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018D0945 [Accessed 04 Sep 2024].
World Health Organization . WHO H5 reference laboratories and the terms of reference. https://www.who.int/initiatives/global-influenza-surveillance-and-response-system/h5-reference-laboratories [Accessed 04 Sep 2024].
World Health Organization . Global HIV programme laboratory network. https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/hiv/treatment/hiv-drug-resistance/laboratory-network [Accessed 04 Sep 2024].
World Health Organization . Measles and rubella laboratory network. https://www.who.int/europe/initiatives/measles-and-rubella-laboratory-network [Accessed 04 Sep 2024].
World health organization . https://polioeradication.org/polio-today/polio-now/surveillance-indicators/the-global-polio-laboratory-network-gpln/ [Accessed 04 Sep 2024].
World Health Organization . TB supranational reference laboratory network (SRLN). https://www.who.int/groups/tb-supranational-reference-laboratory-network [Accessed 04 Sep 2024].
World Health Organization . Prequalification of medical products. https://extranet.who.int/prequal/ [Accessed on 04 Sep 2024].
European Centre for Disease Prevention and Control . European COVID-19 reference laboratory network (ECOVID-LabNet). https://www.ecdc.europa.eu/en/about-ecdc/what-we-do/partners-and-networks/disease-and-laboratory-networks/european-covid-19 [Accessed 04 Sep 2024].
European Centre for Disease Prevention and Control . European reference laboratory network for TB (ERLTB-Net). https://www.ecdc.europa.eu/en/about-us/partnerships-and-networks/disease-and-laboratory-networks/erltb-net [Accessed 04 Sep 2024].
European Centre for Disease Prevention and Control . European reference laboratory network for human influenza (ERLI-Net). https://www.ecdc.europa.eu/en/about-us/partnerships-and-networks/disease-and-laboratory-networks/erlinet [Accessed 04 Sep 2024].
The World Anti-Doping Agency (WADA) . https://www.wada-ama.org/en/anti-doping-partners/laboratories [Accessed 04 Sep 2024].
The World Anti-Doping Agency (WADA) . World anti-doping code international standard laboratories 2021. Montreal, Quebec, Canada; 2021. https://www.wada-ama.org/sites/default/files/resources/files/isl_2021.pdf [Accessed 04 Sep 2024].
The World Anti-Doping Agency (WADA) . List of WADA-accredited laboratories. https://www.wada-ama.org/en/resources/lab-documents/list-wada-accredited-laboratories [Accessed 04 Sep 2024].
Eurotransplant Reference Laboratory (ETRL) . https://etrl.eurotransplant.org/about-eurotransplant/about-the-etrl/ [Accessed 04 Sep 2024].
European Federation for Immunogenetics (EFI) . https://efi-web.org/ [Accessed 04 Sep 2024].
European Federation for Immunogenetics (EFI) . Constitution of the European Federation for immunogenetics. https://efi-web.org/fileadmin/Efi_web/About_EFI/Constitution/2023-04-28_Constitution_EFI_English.pdf [Accessed 04 Sep 2024].
Harmer, A, Mascaretti, L, Petershofen, E. Accreditation of histocompatibility and immunogenetics laboratories: achievements and future prospects from the European Federation for immunogenetics accreditation programme. HLA 2018. https://doi.org/10.1111/tan.13289 . Epub ahead of print. PMID: 29722176.
doi: 10.1111/tan.13289
European Federation for Immunogenetics (EFI) . EFI accredited laboratories. https://efi-web.org/accreditation/efi-accredited-laboratories [Accessed 04 Sep 2024].
Association for the Advancement of Blood & Biotherapies . https://www.aabb.org/standards-accreditation/accreditation/accredited-facilities/aabb-accredited-blood-banks-transfusion-services-and-blood-centers [Accessed 04 Sep 2024].
College of American Pathologists Accreditation . https://www.cap.org/laboratory-improvement/accreditation [Accessed 04 Sep 2024].
U.S. FDA clinical laboratory Improvement Amendments (CLIA) . https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia [Accessed 04 Sep 2024].
Revelli, N, Villa, MA, Paccapelo, C, Manera, MC, Erba, E, Truglio, F, et al.. The immunohaematology reference laboratory: the experience of the Policlinico Maggiore hospital, Mangiagalli and Regina Elena foundation, Milan. Blood Transfus 2009;7:94–9. https://doi.org/10.2450/2008.0040-08 .
doi: 10.2450/2008.0040-08
ISO 21151:2020 . In vitro diagnostic medical devices - requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples . Geneva, Switzerland: International Organization for Standardization (ISO); 2020.
Bureau International des Poids et Mesures (BIPM). https://www.bipm.org/en/ [Accessed 04 Sep 2024].
Miller, WG, Jones, GR, Horowitz, GL, Weykamp, C. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 2011;57:1670–80. https://doi.org/10.1373/clinchem.2011.168641 .
doi: 10.1373/clinchem.2011.168641
ISO 15195:2018 . Laboratory medicine - requirements for the competence of calibration laboratories using reference measurement procedures . Geneva, Switzerland: International Organization for Standardization (ISO); 2018.
ISO 17511:2020 . In vitro diagnostic medical devices - requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples . Geneva, Switzerland: International Organization for Standardization (ISO); 2020.
ISO 15193:2009 . In vitro diagnostic medical devices - measurement of quantities in samples of biological origin - requirements for content and presentation of reference measurement procedures . Geneva, Switzerland: International Organization for Standardization (ISO); 2009.
ISO 15194:2009 . In vitro diagnostic medical devices - measurement of quantities in samples of biological origin - requirements for certified reference materials and the content of supporting documentation . Geneva, Switzerland: International Organization for Standardization (ISO); 2009.
JCTLM Accurate results for patient care [Internet] . Home - JCTLM. https://jctlm.org/ [Accessed 04 Sep 2024].
JCTLM Accurate results for patient care [Internet] . JCTLM database. https://www.jctlmdb.org/#/app/home [Accessed 04 Sep 2024].
Siekmann, L. Requirements for reference (calibration) laboratories in laboratory medicine. Clin Biochem Rev 2007;28:149–54.
RELA - IFCC external quality assessment scheme for reference laboratories in laboratory medicine http://dgkl-rfb.de:81 [Accessed 04 Sep 2024].
ISO 15189:2022 . Medical laboratories – requirements for quality and competence . Geneva, Switzerland: International Organization for Standardization (ISO); 2022.
Isaacs, D, Fitzgerald, D. Seven alternatives to evidence based medicine. BMJ 1999;319:1618. https://doi.org/10.1136/bmj.319.7225.1618 .
doi: 10.1136/bmj.319.7225.1618
Directorate-General for Health and Food Safety . Expression of interest open – possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices. https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en [Accessed 04 Sep 2024].
International Laboratory Accreditation Cooperation . https://ilac.org/ [Accessed 04 Sep 2024].