MDCG 2020-16 Rev.3: IVDR Classification Rules
IVD news July 9, 2024MDCG 2020-16 is a key document outlining the classification rules for in vitro diagnostic medical devices (IVDs) under the EU... read more
IVDR Performance Studies and the ISO 20916:2024 Revision
IVD news April 2, 2024ISO 20916: Introduction ISO 20916, “Clinical performance studies using specimens from human subjects – Good study practice” was first published... read more
Importing IVDs for Performance Studies in Europe
IVD news December 3, 2023The In Vitro Diagnostic Medical Devices Regulation (IVDR) has introduced a stringent regulatory framework for the importation of In Vitro... read more
The Role of a IVDR Legal Representative in Clinical Performance Studies
IVD news December 3, 2023In the field of medical device regulation, the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) exemplifies the EU’s... read more
FDA Laboratory Developed Tests (LDTs) Regulation
IVD news October 4, 2023FDA’s new LDT regulation underscores the vital role of IVD CROs in compliance and safety. Phased over four years without... read more
MDx: Your Dedicated CRO for IVD Clinical Studies in the EU
IVD news August 24, 2023Introduction In the rapidly evolving world of in vitro diagnostics (IVD), manufacturers are increasingly understanding the need for rigorous clinical... read more
Monkeypox Diagnostic Test Specifications: Navigating WHO’s TPPs
IVD news August 24, 2023WHO publishes specifications for monkeypox tests The World Health Organization (WHO) has recently unveiled two pivotal Target Product Profiles (TPPs)... read more
Navigating the IVDR CDx Certification Pathway
IVD news August 24, 2023The evolving landscape of Companion Diagnostics (CDx) introduces complexities in regulatory and certification processes. Engaging in IVDR Companion Diagnostic Consulting... read more
IVDR Transition: Insights from the Dutch Authority
IVD news August 11, 2023State of play of IVDR Transition: In the realm of in vitro diagnostics (IVD), a seismic shift is underway as... read more
IVD Regulatory Services by MDx CRO
IVD news August 9, 2023At MDx CRO, our specialized IVD regulatory services cater not only to in vitro diagnostic medical device manufacturers, companion diagnostics... read more
Companion Diagnostics IVD Consultancy within the EMA Framework: Comprehensive Guidance
IVD news August 8, 2023The field of companion diagnostics IVD (CDx) represents a confluence of technological innovation, regulatory compliance, and patient care. As personalized... read more
Influenza Assays: Risk Classification Under IVDR
IVD news July 27, 2023New position statement published by the IVD expert panel on influenza viruses MDx CRO, an IVD consultancy and CRO company,... read more
IVD Consultancy: Balancing Expertise & Cost-Efficiency with MDx CRO
IVD news July 27, 2023Striking a balance between expertise and cost-efficiency in IVD consultancy can be a tricky task, especially within the European Union’s... read more
Clinical Molecular Genetics (CMG) Under the Lens of the EU IVDR, MDCG and MEDDEV.
IVD news July 24, 2023At the crossroads of healthcare and technology, Clinical Molecular Genetics (CMG) emerges as a keystone, bridging molecular biology and genetics... read more
IVDR Compliance: Progress in EU Reference Laboratories and consequences for High-Risk IVDs
IVD news June 22, 2023EU Commission evaluates EURLs The European Commission is making significant progress in evaluating applications for EU reference laboratories (EURLs) to... read more
Companion diagnostic studies: BSI & TÜV SÜD Lead the Way in CDx Certification
IVD news June 6, 2023The field of personalized medicine is experiencing notable progress as BSI and TÜV SÜD, two of the largest Notified Bodies... read more
New Regulation on In Vitro Diagnostic Medical Devices in Spain: Are You Ready?
IVD news June 2, 2023Are 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?
IVD news May 10, 2023What is the regulatory process for IVD in Europe, and which are the most important aspects of it? Continue reading... read more
IVDR Compliance Made Easy: The Importance of an IVDR Pre-Submission Assessment by MDx CRO
IVD news May 3, 2023What are the most important things you’ll need to know when it comes to IVDR pre-submission assessment? Continue reading. The... read more
