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Delayed Implementing Regulation On Annex XVI Common Specifications Finally Adopted

 
• By Amanda Maxwell

While delays with aspects of the implementation of the Medical Device Regulation are all too familiar, threat of action at European Court of Justice level is unprecedented. But such measures have paid off for manufacturers of non-medical devices.

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Manufacturers of medical devices that come under the scope of the Medical Device Regulation (MDR) but that do not have an intended medical purpose will now have an opportunity for their products to be CE marked in the context of the regulation for the first time.

This is following news that the European Commission’s Implementing Regulation laying down common specifications for groups of products without an...

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Medtech Must Address AI Risks Now Or Jeopardize Its Future Potential, Expert Warns

 
• By Amanda Maxwell

Urgent action is needed to address gaps in how risks from medical devices and diagnostics utilizing AI are identified, mitigated and managed. So says James Pink, renowned medtech regulatory expert in an interview with Medtech Insight.

Germany Readies For Its EPR October Revolution

 
• By Ashley Yeo

Germany’s electronic patient record – ePA – is a flagship initiative of the ongoing national healthcare reform. The medtech industry welcomes rollout of the ePA while calling for further improvements.

No EUDAMED, No Market: ‘Waiting Until Mandatory Deadline Is Risky’

 
• By Natasha Barrow

EirMed CEO Richard Houlihan warns that EUDAMED (the European database on medical devices) publication delays may harm medical device manufacturers. Currently, only a fraction of the required uploads have occurred, creating potential compliance risks as the mandatory deadline approaches.

German Health Researchers Prep for Possible Disruptions to PubMed, ClinicalTrials.gov

 
• By Elizabeth Orr and Francesca Bruce

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

More from Geography

No EUDAMED, No Market: ‘Waiting Until Mandatory Deadline Is Risky’

 
• By Natasha Barrow

EirMed CEO Richard Houlihan warns that EUDAMED (the European database on medical devices) publication delays may harm medical device manufacturers. Currently, only a fraction of the required uploads have occurred, creating potential compliance risks as the mandatory deadline approaches.

Oura Gets Competitors Banned From US Market, But Faces Ultrahuman Countersuit

 
• By Elizabeth Orr

The US International Trade Commission has banned smart rings from Ultrahuman and RingConn after Oura Health's patent infringement case. Ultrahuman countersued, claiming Oura infringes its intellectual property. Sales and marketing of the affected rings will cease on October 22.

Study Finds Public Companies Behind Most Recalled AI Devices

 
• By Elizabeth Orr

A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.