Start Using PMS Guidance Ahead Of June Regulation, Says UK MHRA

Priority Accorded To Incident Traceability And Patient Safety In UK Regulator’s Device Program

The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.

GUIDANCE CONCEPT
The MHRA is to issue new guidance on biosimilars • Source: Shutterstock

New guidance has been published by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to help medtech manufacturers prepare for new post-market surveillance (PMS) regulations that will apply in Great Britain from 16 June 2025.

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Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.

Wired Health: Women Of Wearables Shares Market Outlook

 

Medtech Insight sat down with Anja Streicher, chief marketing officer at Women of Wearables, a global community offering events and education resources to support the femtech industry, to discuss trends in the women's wearables tech market, challenges and innovators pushing the boundaries.

Medtech Regulatory System, IDAP And CERSI Top UK MHRA Agenda In March Update

 
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Britain’s medtech system progress, smarter ways of working at the agency and getting smarter AI and digital technologies into circulation for patients, were themes woven through the UK MHRA board’s 18 March meeting.

Wired Health: One-Size-Fits-All Wearables Don’t Work For Women’s Health

 

Wearable technology must address women’s unique needs, said Anja Streicher, Women of Wearables chief marketing officer. Samphire Neuroscience and Amira Health demo wearable solutions for PMS and hot flashes at Wired Health.

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Global Medtech Guidance Tracker: March 2025

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

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AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
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