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

EU Designates 17th Notified Body Under MDR

 
• By Amanda Maxwell

Despite COVID-19 distancing measures and fears that new notified body appointments would grind to a halt, there is now a new notified body for the EU Medical Device Regulation.

Slovakia

Slovakia’s 3EC has become the 17th notified body to be designated against the EU’s Medical Device Regulation.

This is the second notified body designated in central and eastern Europe – Hungary’s CE Certiso was appointed in late...

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

EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 
• By Amanda Maxwell

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

‘Eyes – A Window Into The Heart’: Retinal AI Tool Predicts Future Risk Of Heart Attack And Stroke

 
• By Natasha Barrow

A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.

PFA Market Surges As UK NICE Opens Doors And US FDA Approves Boston, J&J Incremental Innovations

 
• By Natasha Barrow

The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.

European MedTech Keeps Calm Despite US Threats Of 30% Tariffs

 
• By Amanda Maxwell

MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.

More from Geography

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
• By Elizabeth Orr

US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the

House Bill Calls For ‘Non-Flushable’ Label On Personal Wipes

 
• By Eileen Francis

The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.

PFA Market Surges As UK NICE Opens Doors And US FDA Approves Boston, J&J Incremental Innovations

 
• By Natasha Barrow

The pulsed-field ablation market is surging, with the UK NHS opening doors and FDA updates for major players. Medtech Insight spoke with Steven Mickelsen, founder of Farapulse (the first clinically approved PFA system), about the sector's growth and his new venture, Field Medical.