Spanish AEMPS Latest To Gain Notified Body Designation Under EU Medical Device Regulation

At last, Spain has its first notified body under the MDR.

map of Spain with push pin marker

The Spanish Agency for Medicines and Healthcare Products’ Medical Devices Certification Division has been designated as a notified body under the EU Medical Device Regulation.

This means that there is now a total of 31 notified bodies designated under the MDR in the EU, and seven under the IVD Regulation.

More from Europe

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By 

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 

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

 

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 

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

 

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

 

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 

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.