Implementation of remote monitoring of cardiac implantable electronic devices (CIEDs) in clinical practice – Clinical and legal aspects

Learning objectives 

After watching this webinar, participants will understand:

• the EU’s 2021 Medical Device Regulation (MDR) and how guidelines for remote monitoring of CIEDs support the necessity for social distancing during the pandemic;
• the barriers, perspectives, and critical issues concerning local and nationwide remote monitoring systems to determine which system could most efficiently achieve standardised follow-ups of patients with CIEDs; and
• how to compare local vs. global perspectives in remote monitoring of patients with CIEDs by defining the availability, accuracy, cost-effectiveness, and clinical outcomes of possible post-implantation patient management solutions.

Needs assessment and expected educational outcome

To tackle the legal and regulatory barriers pertinent to remote follow-up of CIEDs, including assurance of data security. To define clinical and technical benefits when remote follow-up of CIEDs is implemented, highlighting the importance of daily transmissions. To clarify important MDR issues that influence implementation of remote monitoring of CIEDs. To demonstrate through clinical data the improved patient outcomes and cost-effectiveness of remote monitoring of CIEDs