1. Medtech Insight

NoBoCap: Notified Bodies Want To Deliver More Transparency And Predictability

Start-ups And SMEs Are Underprepared - Through No Fault Of Their Own

 
• By Amanda Maxwell

Speakers focused on whose role it is in the EU to support manufacturers who struggle to interpret the medtech regulations.

Businessman hands holding empty transparent sphere
• Source: Shutterstock

The current level of inconsistency in the interpretation of the EU’s Medical Device and IVD Regulations, which has lead to a continued avalanche of guidance, is a major factor in generating the need for more support for manufacturers.

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 Medtech Insight

Three Steps To Investor Heaven For Medtech Founders: Articulate, Explain, Clarify

 
• By Ashley Yeo

Capital remains available for good healthtech projects, but it is more concentrated and harder to find than of late. Founders and inventors must know how to unlock it. The BioWales 2025 investor panel told them where they could be going wrong.

Aneira Health Launches New Precision Medicine Platform Exclusively For Women

 
• By Natasha Barrow

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By Ashley Yeo

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

Thermo Fisher Cuts Annual Profit Outlook Amid Estimated $400M Tariff Hit

 
• By Shubham Singh

Thermo Fisher is aggressively managing its supply chain and cost base using its Practical Process Improvement (PPI) Business System. The company is also increasing investments in US-based manufacturing and R&D, with around $2bn allocated to bolster domestic operations.

More from Business

Ultrahuman Launches Home Health Monitoring

 
• By Natasha Barrow

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

HistoSonics’ Edison System Gains Limited UK Access, While Awaiting CE Marking

 
• By Shubham Singh

While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
• By Marion Webb, Shubham Singh, and Nancy Pham

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.