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

Orphan Devices Pilot Program Tackles Parliament’s Proposal Head On

 
• By Amanda Maxwell

The need for the EU to foster the development of orphan devices, intended for smaller patient populations with less commercial promise, is well documented. At last, action is starting.

babies
Infants Are Among Those Who Benefit From Orphan Devices For Rare Diseases • Source: Shutterstock

The European Medicines Agency has introduced a pilot program for expert panels to assist with the development and evaluation of orphan medical devices.

Challenges Of Orphan Devices Reaching Children

The guidance document, MDCG 2024-10 Clinical evaluation of orphan medical devices, points out that in many cases, orphan devices are intended for use solely or predominantly in minors and paediatric populations, and/or in emergency situations.

But, it says, generating clinical data efficiently for small patient populations is difficult, especially for vulnerable groups due to ethical and regulatory requirements, including infants and children. 

Compliance with MDR requirements, including certification, it says, can lead to increased and unpredictable financial costs, hindering manufacturers from placing orphan devices on the EU market due to low sales not covering expenses.

This program provides free advice to selected manufacturers and notified bodies on orphan device status and the data needed for...

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

Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

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.

More from Geography

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 
• By Brian Bossetta

US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.

Medtech Experts Debate EU Recertification Gridlock

 
• By Amanda Maxwell

Modifying or doing away with the EU medtech recertification requirement is far from straightforward. Four experts from an EU national authority, an EU notified body trade association and industry, plus a well-known medtech consultant, reflect on how to move forward.

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

 
• By Brian Bossetta

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.