EU MedTechs Welcome New Commissioner With List of Demands

  
Generate a summary of this article
Listen to this article
Beta

So far, calls for much needed changes to the medtech regulatory system have focused on the Medical Device Regulation. Don’t neglect the IVD Regulation, industry says.

leadership change
Changes Are Needed To Medical Device And IVD Regulations • Source: Shutterstock

The European medical technology industry is calling on the incoming European Health Commissioner, Olivér Várhelyi, to prioritize the regulation of diagnostic technologies as a crucial component of the overall healthcare system and not just to focus on the regulation of medical devices that come up the scope of the Medical Device Regulation (MDR).

Key Takeaways
  • Simplification of requirements: Reducing the administrative burden on companies to expedite the approval process.

In a joint statement responding to the priorities for medtech regulation outlined in the mission letter from Ursula von...

Medtech Insight Podcast

Keep up with the top medtech business and regulatory news.

Medtech Insight brings you interviews and analysis, on the go.

SpotifyApple PodcastsWebsite

More from Compliance

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
• By Nabil

Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

Global Medtech Guidance Tracker: September 2024

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Global Medtech Guidance Tracker: September 2024

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Updated Notified Body Conduct Code Explains Permitted Structured Dialogue

There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document sheds some useful light.

More from Medtech Insight

Test Focus Of Tariff Conversations Shifts To Stability, AdvaMed Says - Clone

 
• By Elizabeth Orr

AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.

US Original PMAs and Panel-Track Supplementss

 
• By Olga Zviezdicheva, Reed Miller, and Nabil

Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.

Test Focus Of Tariff Conversations Shifts To Stability, AdvaMed Says

 
• By Elizabeth Orr

AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.