2. >>Policy & Regulation
  3. >>Regulation

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

EU still figuring out best implementation of MDR on the 8th anniversary of its adoption.

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

KORONADAL CITY, PHILIPPINES – JANUARY 28, 2017: Rubik's Cube was invented in 1974 by Hungarian sculptor and professor of architecture Erno Rubik. Hands of a young lady trying to solve the puzzle. - Image
Finding ways to simplify and better harmonize EU medtech regulations is a tricky challenge for the European Commission • Source: Shutterstock

The EU needs to change its medtech regulatory system but, at the same time, it also needs stability and to ensure patient safety remains the top priority.

In response to these imperatives, the European Commission is planning a way forward that will simplify procedures within the system....

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 Regulation

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

 
• By Ashley Yeo

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 Elizabeth Orr

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 Ashley Yeo

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.

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
• By Amanda Maxwell

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

More from Geography