The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are ...
As journalists, we always hope our words will resonate with readers. But we don't always like the reason why our words strike a chord. This was the experience one of our writers, Heather R. Johnson, ...
OTTAWA, ON, Feb. 17, 2026 /CNW/ - On February 26th, Claigan will be hosting a walkthrough of all the elements of an EU MDR Justification Document. This webinar will be the most tangible walkthrough of ...
The European Commission’s Medical Device Coordination Group (MDCG) this week issued guidance explaining the process for transitioning CE certificates for devices containing an ancillary substance that ...
Under MDR, devices addressing sleep-related conditions—particularly those involving neuromuscular stimulation—are subject to classification, safety assessment, and performance documentation.
The Drugs Technical Advisory Board (DTAB) has agreed with a proposal to amend the Medical Devices Rules (MDR), 2017, to include definition of reportable events related to medical devices, in a move to ...
OTTAWA, ON, Feb. 17, 2026 /PRNewswire/ - On February 26th, Claigan will be hosting a walkthrough of all the elements of an EU MDR Justification Document. This webinar will be the most tangible ...
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