The Situation: The transition to the new so-called Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"), which establish new rules for the placing on the market of medical ...

The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices ...

Dr. Eckhard Alt, MD, PhD, Executive Chairman of InGeneron, Inc. stated that receipt of MDR certification marks an important ...

Acarix today announced its CADScor®System has successfully achieved certification under the European Union Medical Device ...

P&F Products and Features GmbH, a global heart valve MedTech company focused on transcatheter solutions for structural heart ...

A European Union regulation for medical devices produced and sold in the bloc has boosted cross-border expansion opportunities for firms that have adapted to the new rules, according to Mark Braganza, ...

The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic. According to the European Commission, the Medical Devices ...

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" ...

LE MONT-SUR LAUSANNE, Switzerland--(BUSINESS WIRE)--Regen Lab, a global commercial-stage medical technology company specializing in the research, development, registration, manufacturing and ...

Designers and developers of medical devices are aware of the relevance and risks involved in single faults, which must be avoided in all states of operation. However, the dynamics of development, ...

Medical devices are becoming increasingly connected to other devices, the Internet, or hospital networks to serve functions that improve healthcare and enhance treatment options. According to ...