Dermanostic: A Legal Guinea Pig Impacted By MDR’s Regulatory Gaps?

How MDR's Lack Of Clarity Is Destabilizing Innovation

With the latest ruling in Germany, there is speculation that the Medical Device Regulation’s confusing Article 11 on software or the device’s timing of gaining its class I category may be to blame for the invidious position Dermanostic has found itself in.

Guinea Pig

There has been another ruling in the legal tussle over the classification under the Medical Device Regulation of an app that some contend is not even a medical device.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

More from Geography

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By 

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.