Medical and Healthcare Products Regulatory Agency (MHRA) has released new guidance to help manufacturers meet UK medical ...

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.

MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...

The MHRA has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.

AI was a key theme at OCT Medical Devices 2025, yet human sensibility appears to be the true differentiator in clinical trial ...

In large part, this has meant navigating the requirements of the European Union’s Medical Device Regulation (EU MDR). Introduced in 2017, the MDR mandates sweeping regulatory reforms that are ...

In this article, we consider how existing regulations impact the use of AI in the health care space, in relation to (i) AI as a medical device, (ii) ensuring the appropriate use of health data ...

Arterex, a global medical device design, development and contract manufacturing company, has acquired Phoenix S.r.l., a ...

As AI in the medical device space rises, it likely means 2025 will be another challenging year for cyber threats in ...

Experts from the medical devices industry are not quite happy with the Budget as many of their expectations were not met ...