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 ...
On January 21 2025, the Council of the European Union (Council) announced its decision to adopt the Regulation of the European Parliament and of ...
MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...
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.
Cybersecurity has become a leading priority for manufacturers of embedded systems and IoT devices. The rapid proliferation of ...
Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need ...