1. Medtech Insight
  3. >>Europe

In Case You Missed It: Top 10 Gray Sheet Stories In June

The most popular online stories last month in The Gray Sheet included a "Compliance Corner" piece on nightmare scenarios firms have experienced during facility inspections; a scoop on the new chief of device evaluations at FDA; and our coverage of the dynamic regulatory situation in Europe.

Industry insiders dished on nightmare scenarios companies have faced during FDA inspections in the most popular Gray Sheet story last month. And our exclusive report that the US agency's Office of Device Evaluation has a new permanent director who comes from a career in industry attracted significant reader attention as well.

Meanwhile, our coverage of the unpredictable situation in Europe, with regulatory reforms speeding toward adoption just as the UK voted to separate from the European Union, captured significant web hits...

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

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

More from Geography