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
The diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (...
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| Veröffentlicht in: | Clinical chemistry and laboratory medicine 2021-02, Vol.59 (3), p.491-497 |
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| creator | Bank, Paul C.D. Jacobs, Leo H.J. van den Berg, Sjoerd A.A. van Deutekom, Hanneke W.M. Hamann, Dörte Molenkamp, Richard Ruivenkamp, Claudia A.L. Swen, Jesse J. Tops, Bastiaan B.J. Wamelink, Mirjam M.C. Wessels, Els Oosterhuis, Wytze P. |
| description | The
diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of
diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs. |
| doi_str_mv | 10.1515/cclm-2020-1384 |
| format | Article |
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diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of
diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.</description><identifier>ISSN: 1434-6621</identifier><identifier>EISSN: 1437-4331</identifier><identifier>DOI: 10.1515/cclm-2020-1384</identifier><identifier>PMID: 33554568</identifier><language>eng</language><publisher>Germany: De Gruyter</publisher><subject>Complications ; diagnostic medical devices regulation (IVDR) ; Diagnostic systems ; diagnostic test approval ; implementation ; Laboratories ; laboratory developed test ; laboratory medicine ; Legislation ; medical device legislation ; Medical equipment ; Medical laboratories ; quality assessment</subject><ispartof>Clinical chemistry and laboratory medicine, 2021-02, Vol.59 (3), p.491-497</ispartof><rights>2020 Walter de Gruyter GmbH, Berlin/Boston</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2911-702aed982499a707e237627bd48889393049e91024a03a446716c6f67f7332d93</citedby><cites>FETCH-LOGICAL-c2911-702aed982499a707e237627bd48889393049e91024a03a446716c6f67f7332d93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.degruyter.com/document/doi/10.1515/cclm-2020-1384/pdf$$EPDF$$P50$$Gwalterdegruyter$$H</linktopdf><linktohtml>$$Uhttps://www.degruyter.com/document/doi/10.1515/cclm-2020-1384/html$$EHTML$$P50$$Gwalterdegruyter$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,66497,68281</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33554568$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bank, Paul C.D.</creatorcontrib><creatorcontrib>Jacobs, Leo H.J.</creatorcontrib><creatorcontrib>van den Berg, Sjoerd A.A.</creatorcontrib><creatorcontrib>van Deutekom, Hanneke W.M.</creatorcontrib><creatorcontrib>Hamann, Dörte</creatorcontrib><creatorcontrib>Molenkamp, Richard</creatorcontrib><creatorcontrib>Ruivenkamp, Claudia A.L.</creatorcontrib><creatorcontrib>Swen, Jesse J.</creatorcontrib><creatorcontrib>Tops, Bastiaan B.J.</creatorcontrib><creatorcontrib>Wamelink, Mirjam M.C.</creatorcontrib><creatorcontrib>Wessels, Els</creatorcontrib><creatorcontrib>Oosterhuis, Wytze P.</creatorcontrib><title>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</title><title>Clinical chemistry and laboratory medicine</title><addtitle>Clin Chem Lab Med</addtitle><description>The
diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of
diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.</description><subject>Complications</subject><subject>diagnostic medical devices regulation (IVDR)</subject><subject>Diagnostic systems</subject><subject>diagnostic test approval</subject><subject>implementation</subject><subject>Laboratories</subject><subject>laboratory developed test</subject><subject>laboratory medicine</subject><subject>Legislation</subject><subject>medical device legislation</subject><subject>Medical equipment</subject><subject>Medical laboratories</subject><subject>quality assessment</subject><issn>1434-6621</issn><issn>1437-4331</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNptUU1rFTEUDaLYWt26lIDrqfmaZAKCSP0qFAqldTvkJXc0bWYyJhkf_YH-LzPv9cOFq5zAueecew9Cryk5pi1t31kbxoYRRhrKO_EEHVLBVSM4p093WDRSMnqAXuR8TQhtW6GeowPOK2hld4j-XP4EDJPDccClwmA2MZkS0y128BtCnMHhArlgk_EW8M0Ut9iXD_gCbBzHOmmKj1PGQ4ojNnjafU3A4xKKdz5bPwc_mapXTL4ZYrKwev3jk2ew3gSfS8Zx2qXwU4E0Jyg7tftsp98_XWBTs_rKrO5V2O7dX6JngwkZXt29R-jqy-fLk2_N2fnX05OPZ41lmtJGEWbA6Y4JrY0iChhXkqmNE13Xaa45ERo0JUwYwo0QUlFp5SDVoDhnTvMj9HavO6f4a6lX6a_jkuq6ua-arSSq07Syjvcsm2LOCYZ-Tn6sJ-gp6dfW-rW1fm2tX1urA2_uZJfNCO6Bfl9TJbzfE7Ym1Ms4-JGW2woe7f-v3GouaqC_8Gep-A</recordid><startdate>20210223</startdate><enddate>20210223</enddate><creator>Bank, Paul C.D.</creator><creator>Jacobs, Leo H.J.</creator><creator>van den Berg, Sjoerd A.A.</creator><creator>van Deutekom, Hanneke W.M.</creator><creator>Hamann, Dörte</creator><creator>Molenkamp, Richard</creator><creator>Ruivenkamp, Claudia A.L.</creator><creator>Swen, Jesse J.</creator><creator>Tops, Bastiaan B.J.</creator><creator>Wamelink, Mirjam M.C.</creator><creator>Wessels, Els</creator><creator>Oosterhuis, Wytze P.</creator><general>De Gruyter</general><general>Walter De Gruyter & Company</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope></search><sort><creationdate>20210223</creationdate><title>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</title><author>Bank, Paul C.D. ; Jacobs, Leo H.J. ; van den Berg, Sjoerd A.A. ; van Deutekom, Hanneke W.M. ; Hamann, Dörte ; Molenkamp, Richard ; Ruivenkamp, Claudia A.L. ; Swen, Jesse J. ; Tops, Bastiaan B.J. ; Wamelink, Mirjam M.C. ; Wessels, Els ; Oosterhuis, Wytze P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2911-702aed982499a707e237627bd48889393049e91024a03a446716c6f67f7332d93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Complications</topic><topic>diagnostic medical devices regulation (IVDR)</topic><topic>Diagnostic systems</topic><topic>diagnostic test approval</topic><topic>implementation</topic><topic>Laboratories</topic><topic>laboratory developed test</topic><topic>laboratory medicine</topic><topic>Legislation</topic><topic>medical device legislation</topic><topic>Medical equipment</topic><topic>Medical laboratories</topic><topic>quality assessment</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bank, Paul C.D.</creatorcontrib><creatorcontrib>Jacobs, Leo H.J.</creatorcontrib><creatorcontrib>van den Berg, Sjoerd A.A.</creatorcontrib><creatorcontrib>van Deutekom, Hanneke W.M.</creatorcontrib><creatorcontrib>Hamann, Dörte</creatorcontrib><creatorcontrib>Molenkamp, Richard</creatorcontrib><creatorcontrib>Ruivenkamp, Claudia A.L.</creatorcontrib><creatorcontrib>Swen, Jesse J.</creatorcontrib><creatorcontrib>Tops, Bastiaan B.J.</creatorcontrib><creatorcontrib>Wamelink, Mirjam M.C.</creatorcontrib><creatorcontrib>Wessels, Els</creatorcontrib><creatorcontrib>Oosterhuis, Wytze P.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Clinical chemistry and laboratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bank, Paul C.D.</au><au>Jacobs, Leo H.J.</au><au>van den Berg, Sjoerd A.A.</au><au>van Deutekom, Hanneke W.M.</au><au>Hamann, Dörte</au><au>Molenkamp, Richard</au><au>Ruivenkamp, Claudia A.L.</au><au>Swen, Jesse J.</au><au>Tops, Bastiaan B.J.</au><au>Wamelink, Mirjam M.C.</au><au>Wessels, Els</au><au>Oosterhuis, Wytze P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The end of the laboratory developed test as we know it? 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diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of
diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.</abstract><cop>Germany</cop><pub>De Gruyter</pub><pmid>33554568</pmid><doi>10.1515/cclm-2020-1384</doi><tpages>07</tpages></addata></record> |
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| subjects | Complications diagnostic medical devices regulation (IVDR) Diagnostic systems diagnostic test approval implementation Laboratories laboratory developed test laboratory medicine Legislation medical device legislation Medical equipment Medical laboratories quality assessment |
| title | 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 |
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