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Why The Humble Swab Could Be A Seriously Disruptive Element In The MDR And IVDR

 
• By Amanda Maxwell

Health care is about to suffer a major setback and some devices and IVDs are going to have to be held back from the market if the regulatory status of the humble swab is not sufficiently recognized and urgently addressed.

Medical healthcare technologist holding COVID-19 swab collection kit, wearing white PPE protective suit mask gloves, test tube for taking OP NP patient specimen sample,PCR DNA testing protocol process

The insufficiently addressed regulatory position of swabs is threatening to cause major interruption to IVDs being certified against the IVD Regulation. Many may be surprised by this since swabs are medical devices.

No Time To Lose

A significant proportion of IVD manufacturers seem unaware of the need to regulate their IVD kits containing swabs and the closer...

Given considerable variation in the performance characteristic of swabs, some IVD manufacturers choose to include them in their kits to reduce the risk of inappropriate swabs being used; but most...

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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.