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 ...

This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the ...

Good morning Eurohubsters, it’s Craig McGlashan here with the Dealflow. We’re always keen to look into ways that the European private equity market differs from the US and one of the biggest sectors ...

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, ...

At the end of each year, we have a habit of looking back at lessons learned, the ups, the downs, the works. And like in 2020 and 2021, the COVID-19 pandemic and related shortage of medical devices ...

SQ Innovation, developer of Lasix® ONYU, today announced two important regulatory milestones in its international expansion strategy: the receipt of a CE marking certificate for the Lasix ONYU device, ...

The European Commission has published the finalized text of the Artificial Intelligence Act (AIA) which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

After a shove from European Parliament, EU member states, and industry stakeholders, the European Commission (EC) issued ...

Linus Health, a digital health company focused on early detection of Alzheimer's and other dementias, announced that its Core Cognitive Evaluation (CCE) platform has obtained European Union (EU) ...

MINNEAPOLIS, Sept. 6, 2023 /PRNewswire/ -- VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for ...

On 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other interested sector) finally has access to ...