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Key Changes In Commission’s Latest Draft EU Standards Request To CEN/Cenelec

 
• By Amanda Maxwell

Medtech companies selling in the EU will be keeping their fingers crossed that the European standards bodies will accept this third standards request from the Commission once the document is finalized.

Time for Standards - Image

The medtech sector is going to be waiting for a long time before it has access to updated and new harmonized standards to be cited by manufacturers to demonstrate compliance with the EU’s Medical Device and IVD Regulations.

Missing Cornerstone Of EU MDR and IVDR

EU standards, while not mandatory for the medtech industry, are one of the cornerstones of EU regulation. Manufacturers may cite harmonized standards to argue they have met...

The European Commission has published a third draft request for standards needed under the MDR and IVDR. This time the deadline for the adoption of all these harmonized standards...

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More from Europe

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

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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.