1. Medtech Insight
  2. >>Geography
  3. >>Europe

EU Policy-Makers Set End-Of-Year Goal To Finalize Device, Dx Reform

The first of five "trilogue" meetings between the European Parliament, the Council of the European Union and the European Commission to reach a settlement on broad-reaching EU device and diagnostics regulatory reforms took place Oct. 13

Issues that were raised during the first of the five pre-scheduled "trilogue" meetings on settling the future European Union Medical Device and In Vitro Diagnostic Regulations included device liability insurance, classification rules, and regulation of aesthetic devices and "in-house"

devices and diagnostics, according to sources with knowledge of the three-hour Oct. 13 session.

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 Europe

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.

£2Bn Industrial Strategy Boost For UK Life Sciences Growth Sector

 
• By Ashley Yeo

The Modern Industrial Strategy is the first of this summer’s UK blueprints for supporting life sciences industrial activity and transforming NHS healthcare delivery. The UK market must also benefit from its own innovation activity, says industry.

More from Geography

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.

Tarver And Makary Emphasize Commitment To At-Home Healthcare Innovations In FDA Podcast

 
• By Elizabeth Orr

FDA officials Michelle Tarver and Marty Makary discussed advancements in home healthcare during a podcast. They highlighted the importance of continuous glucose monitors, emphasized home healthcare's benefits for chronic diseases, and mentioned the agency's efforts to streamline device development.

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.