1. Medtech Insight
  2. >>Geography
  3. >>Europe

Are Latest Challenges Threatening To Push Eudamed Launch Date Into 2023?

 
• By Amanda Maxwell

While nothing is official yet, it seems that the EU is likely to struggle to have two of the six Eudamed modules ready on time. Might this mean a further delay, or will the system be officially launched without them? 

Delayed and on-time signs

The clinical investigations and the market surveillance modules of the new version of the EU medical device database, Eudamed, are reported to be causing the biggest challenges when it comes to setting up all six modules so that the entire database can be launched in 2022.

“We may even see Eudamed being launched officially with one or both missing, Ronald Boumans, senior consultant, regulatory affairs Emergo...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

More from Geography

Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By Ashley Yeo

In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 
• By Brian Bossetta

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By Marion Webb

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.