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Priority Projects For 2024 To Aid IVDR Implementation

 
• By Amanda Maxwell

The latest insights into work conducted to support the implementation of the IVDR show that much has been achieved already. Ongoing projects remain, however, including those that are continuous. 2024 promises to be a busy year. 

Priority List
• Source: Shutterstock

The Medical Device Coordination Group (MDCG) has updated its Joint Implementation and Preparedness Plan for the IVDR, highlighting its priority projects for 2024.

Some two-thirds of the nearly 50 projects set out in the original document in 2021 are now marked as complete,...

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More from Europe

EU Digital Omnibus Meets MDR And IVDR Revisions: Alignment Or Chaos?

 
• By Amanda Maxwell

Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?

Long-Awaited EUDAMED Notice Ushers In New Era Of Compliance

 
• By Amanda Maxwell

After years of delays - and even skepticism in Rome last month when officials hinted at its imminent debut - the long-awaited EUDAMED medical device database release has finally been confirmed

Proposed Revision Of Digital Rules – EU’s Good Start But Medtech Advises Caution

 
• By Amanda Maxwell

The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?

How The EU’s Digital Omnibus Package Could Provide Breathing Space For Medtech

 
• By Amanda Maxwell

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.

More from Geography

interview

What Exact-ly Is In Store For Liquid Biopsy?

 
• By Barnaby Pickering

Ahead of Exact Science’s $21bn dollar acquisition by Abbott, Medtech Insight spoke to the company’s chief medical officer, Tomasz Beer, to learn more about the company’s multi-cancer early detection offering, its wider portfolio of products and to hear more about the direction of the field.

LDTs Aimed At Catching Cancers Early Hold Promise In Reducing Late-Stage Diagnoses, Study Shows

 
• By Brian Bossetta

A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.

How The EU’s Digital Omnibus Package Could Provide Breathing Space For Medtech

 
• By Amanda Maxwell

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.