"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 ...

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.

EU member states are set to launch the EU Health Data Space Regulation for harmonised data transfer on 26 March.

"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 ...

It was highlighted that while the EU seeks zero tariffs on medical devices from India, stringent regulations, including the replacement of Medical Device Directives (MDD) with Medical Device Rules ...

"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 ...

in line with the EU medical device directives, to ensure they are regulated and acceptably safe to use and also perform as the manufacturer/developer intends. However, as of June 2016, there were ...

Specifically, EU regulators are working on an overarching standard to replace existing medical device directives, which have been in place since the 1990s. If anything, regulation will get even ...