MDR/IVDR Amending Document Finally Adopted

Prior notice about device supply interruption is to become mandatory

In this amendment to both the Medical Device and IVD Regulations, the IVD Regulation timelines will be eased and Eudamed will be rolled out before the entire database is ready.

Healios will announce further strategy on acquired assets from Athersys once its policy is finalized, the firm says.
• Source: Shutterstock

The Council of the EU has voted to adopt the amending regulation to the Medical Device and IVD Regulations which enables a gradual rollout of the Eudamed medical device database, further extends the deadline for transitioning to the IVDR for certain IVDs and requires companies to forewarn about potential device supply interruptions.

This means that the text accepted by the European Parliament in April has now passed the final hurdle and will...

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

More from Europe

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

‘UK Must Put Adoption On A Par With Innovation’

 
• By 

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.

More from Geography

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

‘UK Must Put Adoption On A Par With Innovation’

 
• By 

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

 

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.