The surprising global impacts of Europe's In Vitro Diagnostic Regulation (IVDR)

Updated : Wed, September 15, 2021 @ 4:40 AM

A shortcut to understanding how to prepare for IVDR

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:

• Hear from regulatory experts: watch our webinar series on-demand to understand the new roles and responsibilities for your organisation, identify what the impact will be on your product portfolio, and draw up an action plan to maintain supply continuity.
• Download our white paper that summarises the 9 essential things you need to know to set yourself up for success under the new regulation.
• Find helpful links for roadmaps, expert insight articles and more.