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
Clinical Evaluation of Orphan Devices: Navigating MDCG 2024-10
MEDTECH news July 2, 2024The Medical Device Coordination Group (MDCG) recently released guidance MDCG 2024-10, focusing on the clinical evaluation of orphan medical devices.... read more
MDR Investigator´s Brochure: Consolidating MDCG 2024-5 and ISO 14155 for Medical Devices
MEDTECH news June 22, 2024The Investigator´s Brochure (IB) is a critical document in the realm of clinical research for medical devices. As mandated by... 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
Medical Device CRO: How to Qualify Your Clinical Partner
MEDTECH news March 30, 2024Introduction In the highly regulated and competitive world of medical device development, the choice of a Clinical Research Organization (CRO)... read more
Understanding MDCG 2021-6 Rev. 1: A Comprehensive Guide for Clinical Investigations under EU MDR
MEDTECH news March 16, 2024The Medical Device Regulation (MDR) 2017/745 has transformed the EU’s regulatory landscape for medical devices. It aims to boost patient... read more
Why Choose an ISO 14155-Compliant MedTech CRO?
MEDTECH news December 3, 2023Selecting an ISO 14155-compliant MedTech CRO under EU MDR ensures enhanced data reliability and patient safety. This compliance is key... read more
Importing Investigational Devices for Clinical Investigation in Europe
MEDTECH news December 3, 2023The EU Medical Device Regulation (MDR) has established a rigorous regulatory framework for the entry of investigational devices into the... 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
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, 2023FDA’s new LDT regulation underscores the vital role of IVD CROs in compliance and safety. Phased over four years without... 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
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