1. Medtech Insight
  2. >>Policy & Regulation

Study: How Cost And Timeline Uncertainty Plague Medtech In The EU

 
• By Amanda Maxwell

EU study underscores need for reform in predictability, transparency, and cost-efficiency to enhance Europe’s competitiveness and strengthen its global role in health care.

Balancing time and money
Time and costs are both major considerations for medtech manufacturers weighing up the EU market • Source: Shutterstock

The number of medtech manufacturers choosing the EU as their first launch market has dropped by 40% for large and 12% for SME IVD manufacturers, and by 33% for large and 19% for SME medical device manufacturers.

These alarming figures feature in a report illustrating findings from MedTech Europe’s 2024 IVDR and MDR survey.

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 Policy & Regulation

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Trump Taps Food And Drug Law Outsider For FDA Chief Counsel

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

US Puts 15% Tariff On EU Exports But Medtechs Push ‘Zero For Zero’

 
• By Ashley Yeo

The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses that patients will suffer if medtech is not excluded from the tariffs.

Additional Death And Injuries Added To 2024 Philips Ventilator Recall

 
• By Brian Bossetta

Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.

More from Medtech Insight

Additional Death And Injuries Added To 2024 Philips Ventilator Recall

 
• By Brian Bossetta

Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

Stryker Revises FY25 Tariff Estimate To $175M From $200M As EU Trade Pressures Mount

 
• By Shubham Singh

Kevin Lobo, chairman and CEO of Stryker said that the company is not as exposed to China as others and has manufacturing operations in Europe, influencing the overall tariff impact.