1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Questions Remain On Incorporating UDIs Into Health Care System

As part of implementation of unique device identifier requirements, hospitals will need to capture the unique codes in electronic health records and claims forms, but the logistics of doing so are still being worked out.

While companies prepare to implement the unique device identification requirements, questions remain on how the UDIs will be incorporated by hospitals into electronic health records and insurance claims forms. Those steps are essential for UDIs to fulfill their intended purpose of improving device surveillance and data collection, and aiding in recalls and adverse event reporting.

Device companies have until September 2014 to ensure all class III devices have a UDI entered into FDA’s global UDI...

More from Regulation

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

More from Policy & Regulation

UK Trails NHS 10-Year Plan With Launch Imminent

 
• By Ashley Yeo

Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.