On May 26, 2022 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has become fully applicable with major consequences not only for manufacturers of IVDs but also for all diagnostic laboratories, particularly those that manufacture in-house…read more
In recent years, there has been a dramatic increase in the use of digital health tools health in order to improve service quality, system effectiveness, and facility administration. The COVID-19 epidemic hastened this pattern. eHealth, often known as digital health,…read more
Because the electronic system referenced to in Article 73 (Eudamed) will not be ready and completely functioning on the MDR’s effective date, this guideline covers the processes for safety reporting in clinical research in the absence of Eudamed. MDCG 2020-10…read more
To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the best practice guidance documents that each Team NB notified body member had submitted. They then prepared this best practice guidance…read more
Companion Diagnostic in Precision MedicineIVD NEWS 27 November, 2021
65% of EMA and FDA drug approvals involved a biomarker between 2015 and 2019. Currently, 44 CDx are approved by the FDA, and the most relevant categories in terms of the number of approvals are NSCLC and colorectal cancer.