Reading Between The Lines: Is There A Positive Message Hidden In MDCG’s Blame Document?

The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.

Business concept illustration of a businessman being guided by a hand holding a flashlight uncovering arrow sign.
What is the MDCG's recent position paper really trying to say? • Source: Shutterstock

Two leading medtech industry consultants have suggested that a document just published by the Medical Device Coordination Group (MDCG) may implicitly suggest medtech can soon expect the European Commission to publish an implementing act allowing many legacy devices to remain on the market after their certificates have expired under the former directives, or after the Medical Device Regulation deadline of 26 May 2024.

But they expect any leniency to come with be strict conditions. And products where the manufacturer has not applied to...

More from Europe

Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Investors Urged To Prioritize Patient Engagement To Ensure Clients’ Products Succeed

 

To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By 

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

More from Geography

Questions Over UK Prevention Agenda Within NHS 10-Year Plan

 
• By 

The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By 

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.