Introduction to the COMBINE Programme The European Union has taken a significant step towards streamlining combined studies involving medicinal products,... read more
MDCG 2020-16 is a key document outlining the classification rules for in vitro diagnostic medical devices (IVDs) under the EU... read more
ISO 20916: Introduction ISO 20916, “Clinical performance studies using specimens from human subjects – Good study practice” was first published... read more
The In Vitro Diagnostic Medical Devices Regulation (IVDR) has introduced a stringent regulatory framework for the importation of In Vitro... read more
In the field of medical device regulation, the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) exemplifies the EU’s... read more
FDA’s new LDT regulation underscores the vital role of IVD CROs in compliance and safety. Phased over four years without... read more
Introduction In the rapidly evolving world of in vitro diagnostics (IVD), manufacturers are increasingly understanding the need for rigorous clinical... read more
WHO publishes specifications for monkeypox tests The World Health Organization (WHO) has recently unveiled two pivotal Target Product Profiles (TPPs)... read more
The evolving landscape of Companion Diagnostics (CDx) introduces complexities in regulatory and certification processes. Engaging in IVDR Companion Diagnostic Consulting... read more
State of play of IVDR Transition: In the realm of in vitro diagnostics (IVD), a seismic shift is underway as... read more
At MDx CRO, our specialized IVD regulatory services cater not only to in vitro diagnostic medical device manufacturers, companion diagnostics... read more
The field of companion diagnostics IVD (CDx) represents a confluence of technological innovation, regulatory compliance, and patient care. As personalized... read more
New position statement published by the IVD expert panel on influenza viruses MDx CRO, an IVD consultancy and CRO company,... read more
Striking a balance between expertise and cost-efficiency in IVD consultancy can be a tricky task, especially within the European Union’s... read more
At the crossroads of healthcare and technology, Clinical Molecular Genetics (CMG) emerges as a keystone, bridging molecular biology and genetics... read more
EU Commission evaluates EURLs The European Commission is making significant progress in evaluating applications for EU reference laboratories (EURLs) to... read more
The field of personalized medicine is experiencing notable progress as BSI and TÜV SÜD, two of the largest Notified Bodies... read more
Are you ready for the new regulation on In Vitro Diagnostic medical devices in Spain? Learn everything you need to... read more
What is the regulatory process for IVD in Europe, and which are the most important aspects of it? Continue reading... read more
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