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 ...

The Czech startup has surpassed €1 million in funding as its CE-marked HTG Urogram prepares for commercial rollout, helping ...

Traditionally, if medical device manufacturers wanted to get products into a major market quick, they obtained CE Marking in the European Union first. The EU required proof of safety and performance, ...

Under current legislation, the regulatory frameworks of the MDR and the AIA apply in parallel to AIMDs that are a medical device and at the same time are (or incorporate) an AI system. Moreover, most ...

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 ...

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" ...

U.S. Medical Device Testing Services Market to Reach USD 7.05 Billion by 2035 at a 10.16% CAGR, While Europe Benefits from ...