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QMS And Lab Accreditations Allow Russian Regulator To Green Light Eurasian Device System

 
• By Ashley Yeo

Harmonization of medical device regulation in the five member-state Eurasian Economic Union has advanced considerably in recent months – on the sticky issue of Quality Management Systems (QMS) and on the readiness of Russian labs to sign up to the system. There is no turning back now that the system has been declared user-ready.

A recent agreement on quality management systems (QMS) was the last of the second-level Eurasian Economic Union (EAEU) requirements needed before the EAEU medical devices regulatory system can be used in practice. This major, essential piece of the EAEU medical device system that tells manufacturers how to comply with QMS for the whole region was published as a Decision by the Eurasian Commission in October.

QMS is the last of the 13 second-level documents/requirements number. And the timeframe for two of the 10 third-level documents...

More from Europe

Fallouh Healthcare Receives Grant Funding From Innovate UK

 
• By Natasha Barrow

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

UK Trails NHS 10-Year Plan With Launch Imminent

 
• By Ashley Yeo

Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

More from Geography

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Newborn Screening Tests Among FDA Classifications

 
• By Elizabeth Orr

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?