The Upcoming Diagnostics Regulation will potentially impact patient care in a negative way
January 16, 2020

Upcoming workshop organized by Inspire2Live and Diaceutics

The EU In Vitro Devices Regulation; often referred to by its acronym IVDR, comes into full effect in May 2022 after a 5-year transition period. The regulation represents a major change in how In Vitro Diagnostics are regulated in the EU, especially in the field of companion diagnostics (CDx) and laboratory developed tests (LDTs, otherwise referred to as In-house testing). Diagnostic tests are of great importance for patients because these tests guide treatment decisions for each of them.

Concerns have been raised in various quarters, about a number of potential issues with the regulation and its implementation. These concerns become a major problem for patients, if this regulation increases the challenges of an already broken diagnostic ecosystem; resulting in fewer patients getting testing which would prevent them from accessing precision medicines. ​

Inspire2Live & Diaceutics map specific challenges of relevant stakeholders

Prior to the Inspire2live Annual congress a group of lab experts and patient advocates will come together in a half a day workshop, organized by Inspire2live and Diaceutics to reflect and discuss the potential impact of IVDR on patient care.

The focus of this workshop is therefore; to map the specific challenges from relevant stakeholders (patients, notified bodies, labs, clinical scientists), to work on solutions that contribute to a narrative, for an IVDR that facilitates and promotes quality testing for each patient; not one that creates more problems, where even more patients will miss out. ​

The Inspire2live and Diaceutics IVDR Workshop will be chaired by Professor Bert Kersten and will feature a leading NB, presenting the latest information on implementation.

For more information please reach out to:

Piarella Peralta