Companies located outside the European Union (EU) need to designate an EU-authorized representative if they want to sell SARS-CoV-2 in vitro diagnostic devices in EU countries, the EU’s Medical Device Coordination Group (MDCG) has advised.
To View This Article:
Subscribe To Device Daily Bulletin Premium
Device Daily Bulletin Premium Subscription
Upgrade to Device Daily Bulletin Premium to get all the articles in the free publication PLUS more in-depth stories on regulatory and industry developments, FDA inspection and enforcement activities and analysis of market trends. It makes sense of everything successful devicemakers must know and do, delivering the news, analysis and interpretation of industry changes you need to stay compliant and thrive. And it’s combined with timely content from FDAnews management reports and webinars. Learn more