Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
6/14/2022
/ Clinical Evaluations ,
Cybersecurity ,
Diagnostic Tests ,
EU ,
Information Technology ,
Life Sciences ,
Manufacturers ,
Medical Device Data System ,
Medical Devices ,
Medical Evaluation Reports ,
Popular ,
Software
In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more
5/31/2022
/ Certifications ,
Classification ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
EFTA ,
EU ,
European Commission ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Software
The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated...more
Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more
2/25/2021
/ Classification ,
Diagnostic Method ,
EU ,
International Medical Device Regulators Forum (IMDRF) ,
Manufacturers ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Mobile Apps ,
Software ,
Software Developers ,
Therapeutic Services