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

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

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.

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

The "Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course" conference has been added to ResearchAndMarkets.com's offering. The In-Vitro Diagnostic Regulation (EU) 2017/746, which ...

Medical Device Regulation (MDR): A set of regulations in the European Union that governs the approval and monitoring of medical devices to ensure safety and efficacy. This Nature Research ...