Time to read: 1 minute read
Updated : Thu, November 16, 2023 @ 3:00 PM
Originally published : Wed, September 8, 2021 @ 9:38 PM
Updated : Thu, November 16, 2023 @ 3:00 PM
Originally published : Wed, September 8, 2021 @ 9:38 PM
In today’s global environment, even small regulatory changes in one region can impact organisations that are half a world away. When dramatic shifts occur like the European Union’s new In Vitro Diagnostic Regulation (IVDR), organisations in related industries benefit from taking a closer look to minimise disruptions.
Starting in the spring of 2022, companies manufacturing and distributing in vitro diagnostics (IVD) and laboratory developed tests (LDTs) within or into the EU will need to comply with new rules and regulations. The restructured review and approval processes through notified bodies (NBs) have the potential for far-reaching effects on the global reagents and consumables supply chain.
Enacted on 26 May 2017, the EU’s IVDR was designed to improve on the existing In Vitro Diagnostic Directive (IVDD) by enhancing transparency and patient safety. The increased focus on safety necessitates more complex regulations for the molecular diagnostic industry, spanning from manufacturers to distributors.
Many organisations in the industry are still grappling with the implications of the tremendous change required by the IVDR. The date of application (DoA) is rapidly approaching on 26 May 2022 with no signs of postponement despite public outcries that the industry is wildly underprepared for full implementation.
LGC, Biosearch Technologies has set up an IVDR Resource Hub to catch you up to speed on the IVDR:
LGC, Biosearch Technologies is the complete Genomics portfolio from LGC. Providing genomic analysis tools, instrumentation and services to the genomic scientific discovery sector worldwide, with focus on across ag bio, pharma and molecular diagnostics. Visit our home page to view our products and services.
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