How Authorities Should Communicate Globally About Device Threats

Only those countries signed up to the International Medical Device Regulators Forum are automatic members of the new global communication system for risky devices and IVDs.

Globe puzzle
• Source: Shutterstock

The International Medical Device Regulators Forum (IMDRF) has published a post-market surveillance national competent authority report (NCAR) exchange criteria and report form.

This 18-page guidance document describes “a two-way communication system involving confidential information for serious public health issues.”

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 International

Award-Winning Lioness Implant Addresses ‘Silent Emergency’ Of Preterm Birth

 
• By 

The Lioness non-surgical silicon ring implant is designed to put an end to pre-term births, sparing maternal anguish and saving health system costs. PregnanTech won the Biomed Israel 2025 medtech start-up award, and Limor Sandach told In Vivo how a non-digital technology beat off stiff competition.

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

Abbott Lowers Outlook But Headwinds Are Temporary

 

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

Global Medtech Guidance Tracker: June 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

More from Geography

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By 

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.