How To Transfer Surveillance Oversight For IVDs From One EU Notified Body To Another

 
• By Amanda Maxwell

With the final deadlines for legacy products that need to comply with the IVD Regulation on the horizon next year, help is at hand to transfer responsibility for surveillance from one notified body to another. But who will need it and why?

Man passing the baton to partner on track against close up of the track starting point - Image
At Some Point, Surveillance Responsibility For IVDs Must Change Hands

Members of the TEAM-NB association of notified bodies have adopted an agreement specifying the terms of the transfer of the appropriate surveillance activities for legacy IVDs from one notified body to another.

Legacy IVDs are products that remain covered by an IVD Directive notified body certificate during the extended transitional periods they now have to comply with the IVD Regulation.

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

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

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.