Task Force Advocates Making Registries Better Than Sum Of Their Parts

The FDA-endorsed Medical Device Registry Task Force maps out a path toward "coordinated registry networks," starting with pilot projects and 11 prioritized device categories.

Medical device registries need much better coordination so they reflect the same set of device identifiers, shared minimum data elements and definitions and the ability to pool complementary data, according to an FDA-endorsed task force report.

The agency released a report

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 Regulation

MHRA Opens Second AI Airlock Program For Applications

 

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By 

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By 

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By 

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

More from Policy & Regulation

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

 

Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By 

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By 

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.