IVDR Clinical Evidence: EU Guidance Document Spells Out What Is Required

The long-awaited guidance on how to collect and maintain clinical evidence for diagnostic tests under the IVDR has now been published. It reflects the need for a lifecycle approach to device development and regulation.

Gloved hand performs COVID-19 testing in a laboratory setting.
• Source: Alamy (tilialucida / Alamy Stock Photo/Alamy Stock Photo)

Guidance on the general principle of clinical evidence for IVDs has been published by the European Commission’s Medical Device Coordination Group.

The 31-page document, MDCG 2022-2, is the second guidance document to be issued this year, features five-and-a-half pages on...

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

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.

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.

More from Geography

‘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.

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By 

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.