Extensive EU Medtech Regulatory Survey Reveals Scale Of MDR Hurdles And Where Problems Lie

MedTech Europe says solutions are still urgently needed to ensure the MDR is on course and warns that 50% of companies are deprioritizing the EU as launch market, potentially denying EU citizens vital health care.

Climbing_Team
There is still a long and difficult MDR compliance journey ahead

Medical Device Regulation certificates have not been issued yet for over 85% of the more than 500,000 devices previously certified under the Medical Devices Directive or the Active Implantable Medical Devices Directive. Only 69,239 devices have been certified to the MDR in the past three years.

That is the shocking figure just released by MedTech Europe, the EU’s largest medtech industry association, in a

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

More from Europe

More from Geography

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

‘Pathologists Are Hungry For AI-Enabled Digital Pathology’

 

Digital pathology makes it possible to unlock insights previously hidden to the human eye, “reshaping how we diagnose and treat patients,” said Nathan Buchbinder, co-founder and chief strategy officer at Proscia. He shared his views on the future of digital pathology and the lessons he has learned from working with pathologists.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.