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.

Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...

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 ...

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

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

has announced that its X-Guide® Dynamic 3D Surgical Navigation System is the first of its kind to receive certification under the European Union Medical Device Regulation 2017/745, also known as ...

The government also indicated at that time that the new medical device regulations in Great Britain will be closely aligned with the European Union Medical Regulations 2017. The government ...

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

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

The FDA is particularly concerned that supply chain issues are having an adverse impact on neonatal and paediatric patients.

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

Expert warns that In future, smart-connected devices must comply or it will be illegal to sell them in the European Union ...