IVDR Class C Devices: Why Early Notified Body Engagement in 2026 is Critical
- The 2026 deadline for the European Union’s In Vitro Diagnostic Regulation (IVDR) is no longer a distant milestone.
- The shift from the IVDD (In Vitro Diagnostic Directive) to the IVDR represents an increase in scrutiny, evidence expectations and post-market accountability.
- Where once a small subset of legacy devices moved through the system with minimal oversight, today many high impact diagnostics must withstand a level of examination that interrogates every claim, assumption and data point.
Blood test could help predict disease progression and how well treatment will work
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Scientists are developing a test which could one day be used to predict how a patient’s illness will progress, and even how well they will respond to treatment.
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The international team, led by researchers at Imperial College London, has already tested their method (called VeloCD) to successfully predict patients’ outcomes for a range of health conditions, including the likely progression of infectious and chronic disease.
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In a proof-of-concept study they were able confidently predict whether children with acute fever were likely to recover or deteriorate, and whether healthy adults were likely to go on to develop flu or COVID-19 after exposure to the viruses.
Government launches clinical trial reforms
- The MHRA and Health Research Authority (HRA) are introducing the largest package of reforms in over 20 years.
- This will include faster assessment of first in human trials and the introduction of notifiable trials, a fast-track route to allow lower-risk trials to start sooner and modification to be approved quicker, whilst maintaining the highest safety standards.
- The reforms will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace new approaches, including use of early safety data from overseas studies which meets UK standards and computer model simulations which can help to predict how new medicines may behave before they are tested in patients.
WHO and the Stop TB Partnership publish a TB near point-of-care and swab-based testing toolkit
- To support WHO member countries in their efforts to implement new policy recommendations for TB diagnostic testing, the World Health Organization (WHO) and the Stop TB Partnership have published the TB near point-of-care and swab-based testing toolkit (NPOC/swab toolkit).
- This comprehensive set of tools is designed to support implementation of TB near point-of-care nucleic acid amplification tests (NPOC-NAATs) for swabs of sputum and tongue swabs to diagnose tuberculosis (TB) with and without drug resistance.
