About the New and Emerging Technologies (NET) Working Group
NET aims to identify new, emerging and converging technologies, including innovative uses of existing technologies, relevant to medical devices and related areas. NET also works to consider the adequacy of the current regulatory regime for medical devices, as well as any anticipated regulatory changes, in relation to those technologies to identify any challenges and makes recommendations to the Medical Device Coordination Group (MDCG).
Regulatory analysis under the Medical Devices Regulations
The new Regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR) published on 5 May 2017 contain a number of provisions that reflect the scientific and technological progress in information and communication technologies (ICT). The New and Emerging Technologies (NET) Working Group (WG) worked on ICT applications in the past, and this work was fed into the Commission’s considerations, and into the subsequent negotiation process on the MDR and the IVDR. During the past years, the NET WG has followed several ICT applications that qualify as novel devices, in particular from the emerging field of mobile health (mHealth). A representative example of this technology was chosen to present relevant regulatory challenges of this technology. Read the Summary Report NET WG: mHealth technology example regulatory analysis under MDR.