Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments and what is important to know when seeking to do business in the EU.

The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development ...

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 ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...

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.

For example, this applies to medical devices under the EU Medical Device Regulation (MDR). We already have dedicated electronic cross-border health services in place for two systems: e-prescription ...

In the EU, the Medical Device Regulation (MDR) requires manufacturers to conduct continuous post-market surveillance, including monitoring AI model drift and retraining outcomes. This shift toward ...

The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses ...

Stay ahead of cyber threats and regulatory demands—download the full quick guide to fortify your cybersecurity strategy and ...

Imricor receives CE Mark certification for the Advantage-MR system under new European Medical Device Regulation as it hits ...

Following the implementation of the UK's EPR, what other European countries have strong regulation on packaging?