"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 ...

In our safety and pharmacovigilance focus month, just how important is it to have a policy for medical devices ... changes mean the EU is moving away from a directive required by national law ...

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

"Exporting to the EU has become increasingly challenging as the region has replaced the Medical Device Directives (EU-MDD) with the more rigorous Medical Device Rules (EU-MDR)," he noted.

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 ...

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 ...

You can find an indicative list of equipment that falls under the related laws in the directive on WEEE Once you start selling WEEE-labelled products on the EU market ... devices produced in limited ...

Dublin, March 28, 2025 (GLOBE NEWSWIRE) -- The "European Directory of Medical Devices & Diagnostics Companies 2025" has been added to ResearchAndMarkets.com's offering. Profiling more than 2,000 ...

The Commission’s consultation on medical device safety and efficiency ended today, with the industry calling for better alignment between EU regulations and fewer overlaps. Health Commissioner ...