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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 is 2018 – the rest were due in 2016

More from Europe

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

Will NICE’s New Medtech Evaluation Plans Hit the Target for Patients and Industry?

 
• By Ashley Yeo

One year after the UK mooted the Rules-Based Pathway to give medtechs clarity on what can be expected from an evaluation, the devices industry says UK healthtech assessment and adoption processes are still failing to meet the needs of innovators and patients.

More from Geography

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.