A “cyber device" is a device that (1) includes software validated, installed, or authorized by the sponsor as a device or in a device, (2) has the ability to connect to the internet, and (3) contains any such technological characteristics validated, installed, or...
On March 2nd, 2023, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) published a guidance, “Health Industry Cybersecurity – Managing Legacy Technology Security (HIC-MaLTS). The same day the White House published its...
Introduction Remote patient monitoring (RPM) technology allows healthcare providers to monitor patients without requiring them to be physically present in a healthcare facility. The potential use of remote monitoring technologies in patient health is endless in...
On February 25, 2023, Team-NB issued a position paper titled Best Practice Guidance for the Submission of Technical Documentation under Annex II Technical Documentation and Annex III Technical Documentation for Post-Market Surveillance of EU In Vitro Diagnostic...
The FDA Center for Devices and Radiological Health (CDRH) published a Sources Sought document on February 15th, 2023, in which they are conducting market research to identify industry members who are interested in providing services for a future Medical Device Active...
The new medical device regulation for Brazil, Regulation RDC No. 751/2022, issued on 21 September 2022, is now in force as of 01 March 2023. The Brazilian Health Regulatory Agency (ANVISA) updated the prior regulation (No. 185/2001) to provide for risk classification,...
Background Beginning February 27, 2023, companies with early-stage, high-risk medical devices will have the opportunity to start submitting letters of interest to participate in the European Medicines Agency (EMA) scientific advice pilot. This pilot will give an...
The EU Medical Device Coordination Group has recently released document MDCG 2023-3 titled “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices.” Its goal is to help competent authorities, economic...
Reimbursement is a critical part of getting a medical device or in vitro diagnostic (IVD) to market. Reimbursement can impact your design, regulatory strategy, and financial returns on medical devices. Understanding the key components of reimbursement allows for a...
In-house medical devices are exempted from most of the provisions of (EU) 2017/745 (Medical Devices Regulation) and (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation), given that the health institution follows the conditions laid out in Article 5(5) of the...