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

Define, Identify And Protect: How EU Regulators Can Prevent Device Shortages

 
• By Eliza Slawther

There are growing fears that the new EU medtech regulations could result in products used for children or rare diseases vanishing from the market. In an interview with Medtech Insight, regulatory expert Tom Melvin explains how these devices can be protected.

Child Stethoscope
• Source: Shutterstock

“Define, identify and provide solutions” would be the mission statement of Tom Melvin, associate professor of Medical Device Regulatory Affairs at Trinity College, Dublin, Ireland, if he were tasked with preventing vulnerable medical devices from disappearing from the market in the EU.

While capacity bottlenecks, high costs for manufacturers and lengthy assessment times as a result of the EU Medical Device Regulation...

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

New Guidelines Support Early Intervention With Edwards TAVR Device Sapien

 
• By Natasha Barrow

The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

Breast Tissue Regeneration: Tensive’s Journey To Restore ‘Wholeness’ For Cancer Survivors

 
• By Natasha Barrow

Medtech Insight spoke with Sanjay Kakkar, Tensive CEO, about the firm’s breast tissue regeneration implant and its surgical benefits, including a reduced operation time of 74 minutes. He anticipates regulatory approval for Regenera in early 2027.

Asabys Partners Talks SafeHeal €10M Investment At LSI Europe

 
• By Natasha Barrow

SafeHeal has secured an additional €10m for its Colovac device, bringing its total funding to €97.5m. Led by Asabys Partners, this funding offers both economic and clinical benefits, potentially reducing costs and complications associated with temporary stomas.

More from Geography

Malaysia’s MDA At Asia Forum: ‘Regulatory Silos Are Not The Way Forward Anymore’

 
• By Ashley Yeo

MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.

FDA Oversight Still Falling Short on Women’s Safety, Advocate Finds

 
• By Elizabeth Orr

Device safety advocate Michelle Llamas says the FDA’s device review system leaves women at risk, citing weak oversight of 510(k) clearances, delayed safety warnings, and underrepresentation in trials. Her updated report urges stronger monitoring, transparency, and safeguards.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.