Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025 on the European Health Data Space ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has ...

March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming ...

AMSTERDAM (Reuters) - The European Commission is looking at ways to cut overlap in tech rules in response to complaints from ...

Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is ...

This approval further confirms Paragonix’s compliance with the highest quality control standards for medical devices and allows continued access to the European market under the new EU regulations.

The IMCAS World Congress convened over 20,000 attendees from 140 countries, including a diverse mix of leading medical professionals, researchers, and industry representatives. FOR THE sixth time, ...

Medical device establishment licence (MDEL) holders must notify Health Canada at least 5 business days before the day on which a designated medical device will be imported. (Refer to section 62.29(a) ...

The following information is required for Health Canada to consider the exceptional importation and sale of a designated medical device. Health Canada may request additional supporting information if ...

Market Trends Shaping the Future A significant trend driving the European medical devices market is the widespread adoption of telemedicine, with approximately 200 million e-consultations recorded in ...

Reflow Medical announced today that it opened a European subsidiary in Landsberg ... Reflow develops medical devices designed to fill unmet clinical needs in the treatment of complex ...

The regulation entered into force on 18 July 2024 replacing the Ecodesign Directive 2009/125/EC and is said to be essential for achieving the objectives of the 2020 Circular Economy Action Plan. In ...