MEDIcept Insights
A Focus on the Challenges with Utilizing Remote Monitoring in Patient Healthcare
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...
Team NB Position Paper Submission of Technical Documentation Highlights
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...
FDA Seeking Sources for Medical Device Active Surveillance System – Understanding FDA’s Request
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...
New Brazil Regulation for Medical Devices Now In Effect – Steps to Take
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,...
EMA Scientific Advice Pilot for Firms Seeking EU MDR Approval – What Does This Pilot Mean for Medical Device Companies?
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...
New Guidance Released on EU MDR Vigilance Terms and Concepts
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...