The success in intra-European healthcare deals requires regulatory expertise, operational flexibility and market-specific ...

The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products ...

U.S. tariffs on medical products could significantly impact companies with operational footprints in Ireland, Germany, and ...

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 ...

with some references to the existing Medical Device Directives. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to ...

with some references to the existing Medical Device Directives. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep ...

"Exporting to EU has become more difficult as it replaced the Medical Device Directives (EU-MDD) with the more stringent Medical Device Rules (EU-MDR)," he said. Citing an example, he said the new ...

The regulatory environment has become particularly challenging since the EU replaced the Medical Device Directives (EU-MDD) with the more stringent Medical Device Rules (EU-MDR). This transition ...

"Exporting to EU has become more difficult as it replaced the Medical Device Directives (EU-MDD) with the more stringent Medical Device Rules (EU-MDR)," he said. Citing an example, he said the new ...

Inc., a leading developer of innovative medical devices for complex cardiovascular disease, has announced the opening of its European subsidiary in Landsberg am Lech, Germany. This strategic ...