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 ...

MDR Certification Strengthens Resyca's Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS Newswire / January 28, 2025 / Resyca BV, a pioneering leader in the development an ...

NXP recently launched the EdgeLock A30 Secure Authenticator chip, a Common Criteria EAL 6+ certified secure authentication ...

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

Cybersecurity has become a leading priority for manufacturers of embedded systems and IoT devices. The rapid proliferation of ...

European politicians and advocacy groups say the region’s legislation will not dismantle the monopolies of Big Tech companies ...

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

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms ...

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

The Council of the EU has adopted the European Health Data Space (EHDS) regulation, which will make it easier to exchange and access health data at EU level.

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 ...