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Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations

 
• By Amanda Maxwell

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.

Notified bodies will not be able to assess and take certification decisions for all applications before May 26, 2020, the full application date for the MDR.

That is the warning from the EU notified body trade association, TEAM-NB, in a white paper titled "One Year Of Application," published in conjunction with the European Confederation of...

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More from Europe

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

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.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

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.