The European Union's Medical Device Regulation (EU MDR) has become much more sophisticated and specific. Since taking effect in May 2017 the EU MDR includes more challenging protocols, including new ...

Every time there is a major public health scandal, governments respond with “new and improved” regulations. Such has been the case in the wake of the Poly Implant Prothèse breast implant scandal, in ...

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, ...

LONDON (Reuters) - One year on from a breast implant scandal that shook confidence in Europe's light-touch system for regulating medical devices, lawmakers and manufacturers are at loggerheads on ways ...

DUBLIN--(BUSINESS WIRE)--The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ...

Due to the increasing concerns about medical devices' cybersecurity risks, European Union regulators put forward a new set of market entry requirements for medical devices and in vitro diagnostic ...

The "The EU Regulations for Digital Medical Devices with AI Components - A Basket Full of Requirements - What Does a Manufacturer Need to Consider? (Dec 9, 2025)" training has been added to ...

Dublin, Dec. 23, 2025 (GLOBE NEWSWIRE) -- The "Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course ...

Evolus (EOLS) announced the EU Medical Device Regulation certification was received for four unique injectable hyaluronic acid gels under the brand name Estyme, branded as Evolysse in the U.S. market.