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How Legacy Devices Can Remain On Market Once Former Certificates Have Expired

 
• By Amanda Maxwell

Published immediately after the 9 December meeting on the MDR at the Council of the EU, a new position paper explains a way forward for devices whose former MDD and AIMDD certificates are due to expire ahead of certification under the MDR.

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MDCG Document Sheds Light On How One Aspect Of European Commission Latest Proposals Will Work

A new EU position paper has been published which aims to promote a common understanding of, and a uniform approach to, the application of the Medical Device Regulation’s Article 97.

The full title is MDCG 2022-18: Position Paper on the application of Article 97 MDR to legacy devices for which...

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Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 
• By Natasha Barrow

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 
• By Natasha Barrow

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.