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 ...

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

The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for ...

Arterex said the deal expands its capabilities in medical device development, finished device assembly and packaging to ...

Thousands of companies outside Europe in Asia and America are also affected by the new EU regulation. Duesseldorf / Germany ...

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need ...

Brussels: The EU accused China on Tuesday of discriminating against European medical device producers in public ... and was the first under the European Union's International Procurement ...

The HPRA is the national regulator across many different health products: medicines, particularly pharmaceuticals and ...

The European Commission has presented a new action plan to enhance the cybersecurity of the healthcare sector amid a rise in ...

MedTech Europe’s report reflects a lack of clarity over requirements, rising costs, and decreases in innovation activities.