In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the...more
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
After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more
3/11/2021
/ Analytics ,
Clinical Evaluations ,
Document Retention Policies ,
Documentation ,
EU ,
Life Sciences ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Pharmaceutical Industry ,
Safety Reports ,
Software ,
Supply Chain ,
Surveillance
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
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed...more
The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this...more