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Competent Authorities Warn EU Industry Not To Expect All MDR Implementation Tools In Time

 
• By Amanda Maxwell

Preparing all items needed to support the implementation of the EU’s Medical Device and IVD Regulations in time is going to be impossible. Competent authority expert Thomas W Møller explains how work on a third of implementation tasks still remains to be started.

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As controversial as this may sound, it will be impossible to produce guidance on all aspects of the implementation of the Medical Device Regulation by 26 May 2021.

However, “those overseeing implementation need to continue to work together to prioritize what is needed and to manage the roadmap...

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More from Europe

Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

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.

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.

More from Geography

Global Medtech Guidance Tracker: May 2025

 
• By Vibha Sharma

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

Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

J&J MedTech Launches KINCISE 2 Surgical Automated System In US

 
• By Natasha Barrow

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.