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.

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 ...

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

Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.” ...

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 ...

US-based MicroAire Surgical Instruments has acquired NEOSYAD, a developer of technology for adipose tissue engineering.

An EU investigation has found discrimination against European companies in China's public procurement market for medical devices, opening up a new front in the bilateral trade dispute. A report ...

The European Commission said on Tuesday it had found "clear evidence" that EU suppliers of medical devices are not given fair access to China's public tenders, a finding that could lead to ...

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

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