1. Scrip
  2. >>Archive

EU publishes draft regulation on e-labelling of medical devices

 
• By Vibha Sharma

The European Commission has issued its much-awaited draft regulation on e-labelling of medical devices, the final version of which is expected to be adopted on 14 December and enter into force a year later1,2.

The European Commission has issued its much-awaited draft regulation on e-labelling of medical devices, the final version of which is expected to be adopted on 14 December and enter into force a year later1,2.

The proposed regulation sets out conditions under which "instructions for use" in paper format may be replaced by electronic versions with respect to medical devices that are intended for exclusive use by professional users and for which use by other persons is not reasonably foreseen

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Archive

More from Scrip

Novo Nordisk’s CEO Forced Out After Falling Behind In GLP-1 Battle

 
• By Andrew McConaghie

Company surprises investors with Jørgensen's exit but insists its strategy will not change.

In Brief: US FDA Delay Sends Biohaven Shares Down

 
• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Executives On The Move: Pathos Procures CEO From AstraZeneca, New CEO For TME Pharma, And More

Recent moves in the industry include changes at the top at Akamis Bio, Innospera Pharma & Ispen, plus Astellas Korea appoints an ex-Novartis Korea executive.