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

New Pointers For Industry On How To Comply With EU Requirements For Legacy Devices

 
• By Amanda Maxwell

The European Commission has provided an early revision of a critical Q&A document to help manufacturers better understand how to keep legacy products on the EU market.  

Two arrows pointed in different directions on a signpost 3D illustration
• Source: Shutterstock

The European Commission has published a first revision of its Q&A on practical aspects related to the implementation of the amending regulation (EU2023/607) to the Medical Device Regulation. 

The updated 11-page document features a useful revision history box which indicates to the reader the cross-referencing needed to understand...

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

More from Geography

‘UK Must Put Adoption On A Par With Innovation’

 
• By Ashley Yeo

Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.

Sofinnova And NVIDIA Partner To ‘Supercharge’ Computation For European Startups

 
• By Natasha Barrow

European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.