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

EU Regulatory Roundup, October 2023: Notified Bodies Fire On All Cylinders To Manage Challenges

 
• By Amanda Maxwell

Are too few manufacturers making their applications to notified bodies right now or are they applying but being turned away? Tensions are rising as notified bodies try to manage their workload and industry feels increasingly under stress.

Top Stories EU

October saw evidence of the struggles that notified bodies are experiencing in managing their workloads. They are calling for manufacturers to apply to notified bodies now so that they can audit products in a timely and manageable way.

But manufacturers, and especially SMEs, who have suffered the impact of a challenging and piecemeal implementation of the Medical Device...

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

Why EU Innovators Face Growing Barriers With EU Combination Product Regulation

 
• By Amanda Maxwell

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.

UK’s Dementia Trials Accelerator Works To Fast-Track Trial Recruitment

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

Inaccurate Carbon Dioxide Readings Prompt Class I Recall Of Draeger Ventilation Filters

 
• By Brian Bossetta

Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By Ashley Yeo

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

More from Geography

UK’s Dementia Trials Accelerator Works To Fast-Track Trial Recruitment

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

Breathing Easy: Freespira Works To Expand Access To Panic And PTSD Treatment

 
• By Elizabeth Orr

Freespira’s device has been FDA-approved to treat panic disorders and PTSD. CEO Joe Perekupka told Medtech Insight the company’s innovative approach includes patient coaching, insurance partnerships to identify potential users, and lobbying for broader insurance coverage for digital therapeutics.

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.