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

NoBoCap: The EU’s Solution To Its Medtech Notified Body And Innovation Crisis?

 
• By Amanda Maxwell

While the medtech industry has been hammering home the message that the EU medtech regulatory system is failing manufacturers and innovation, moves are already afoot that should address some concerns by improving the capacity and availability of notified bodies.

Innovation concept presented by a consultant in management on webinar screen
Key Takeaways
  • NoBoCap is a new venture aiming to improve the accessibility and capacity of notified bodies and secure pathways for medtech innovation in Europe.
  • It will offer a matchmaking platform connecting market operators with appropriate notified bodies.
  • The project will create a platform for matching notified body staff competency recruitment needs with potential applicants.
  • It will offer a new voice for start-ups and SMEs.

An exciting new venture, NoBoCap, is being set up to ensure that innovative health solutions can reach the EU market more swiftly and efficiently. 

Through NoBoCap (short for Notified Body Increased Capacity) dedicated training models will be set up to increase notified body capacity to better serve the medtech industry given current demand...

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 Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

More from Geography

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Health Literacy Issues Cost Major Economies $303B Per Year, Recent Study Shows

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.