Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and ...

Legacy Devices: How MDR Alters the Landscape Medical devices with valid certifications under the Medical Device Directive (MDD) will have to prepare to adapt to the incoming Medical Devices Regulation ...

The European Commission’s Medical Device Coordination Group (MDCG) on Monday issued a new questions and answers document addressing custom-made medical devices under the Medical Device Regulation (MDR ...

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, ...

Under MDR, devices addressing sleep-related conditions—particularly those involving neuromuscular stimulation—are subject to classification, safety assessment, and performance documentation.

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...

Düsseldorf District Court issues preliminary injunction against Beijing Hanbaihan Medical Devices Co., Ltd. regarding non-CE-marked PRP tubes at MEDICA 2025 MONTHEY ...

LONDON--(BUSINESS WIRE)--Signifier Medical Technologies Limited (“Signifier”), a global leader in medical technology for sleep-disordered breathing, announces that it has achieved the EU MDR ...

ReShape Lifesciences has achieved EU MDR and UKCA certifications for its medical devices, enhancing market access and ensuring safety compliance. ReShape Lifesciences announced that its Quality ...