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Making The Leap From EU MDD To MDR Clinical Evidence (Part 3): Critical Questions Answered

 
• By Amanda Maxwell

Do you know how to avoid the pitfalls when it comes to clinical evidence under the MDR? Or whether evidence gathered outside the US counts? Amie Smirthwaite of Maetrics answers these and other pivotal questions in this third and final part of an interview series with Medtech Insight.

Labyrinth

All manufacturers wanting to be compliant with the new EU Medical Device Regulation, when it fully applies from 26 May 2021, must review their clinical evidence in the light of the new rules. Picking a way through the new MDR requirements it not always easy.

Here, Maetrics’ Amie Smirthwaite explains the potential compliance pitfalls, when a claim of equivalency can be used and how well established technologies are impacted by the new rules, amongst other...

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EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

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• By Natasha Barrow

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

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More from Geography

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.