Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments ...

The success in intra-European healthcare deals requires regulatory expertise, operational flexibility and market-specific ...

It’s the start of the new fiscal year here in the UK and it seems like private equity also has tax on its mind.

The European Society of Cardiology (ESC) has urged the European Commission to revise the Medical Device Regulation (EU ...

EU member states are set to launch the EU Health Data Space Regulation for harmonised data transfer on 26 March.

Marc Pignot, Christian Schübel, Alfred Pauls, Klaas Heinemann discuss their expectations for the new medical device regulations, ahead of the European Parliament's decision this week. On July 10 ...

To avoid overlaps, the industry is calling for aligning MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations ...

March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming ...

Enable is currently working with a number of pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies in combination with the enFuse technology. The ...

The European Union has sent Apple preliminary instructions on how it expects the iPhone maker to comply with interoperability ...