MDR Article 62.2: The Role of Clinical Investigation Legal Representative
MEDTECH news November 25, 2023In the intricate world of medical device regulation, the European Union Medical Device Regulation (EU MDR) stands out as a... read more
Understanding the MDCG 2023-4 Guidance on Medical Device Software and Hardware Combinations
MEDTECH news October 20, 2023The world of medical device regulation is constantly evolving, with regulatory bodies introducing new guidances to keep up with the... read more
FDA Laboratory Developed Tests (LDTs) Regulation
IVD news October 4, 2023The Food and Drug Administration (FDA) recently released a groundbreaking proposed rule on September 29, 2023, aiming to transform its... read more
Understanding MDCG 2020-13: A Guide for Medical Device Manufacturers Preparing Clinical Evaluation Reports
MEDTECH news October 1, 2023The Medical Device Coordination Group (MDCG) plays a key role in setting the rules for medical devices in the European... 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
MDR Transition Period: Updated Q&A Document, Changes & Clarifications
MEDTECH news July 20, 2023The recent amendment of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) through Regulation (EU)... 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
How to Prepare Your Clinical Evaluation Plan Template in 5 Key Steps
MEDTECH news June 9, 2023In this article, we will delve into the intricacies of developing a robust Clinical Evaluation Plan using expert regulatory terminology,... 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
MDR Annex XVI: Regulating Medical Devices Without An Intended Medical Purpose
MEDTECH news June 2, 2023How are medical devices without an intended medical purpose regulated under the MDR Annex XVI? Continue reading to learn 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
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