Rebooting EU Medtech: Appetite For Urgent Discussions To Address Failing Regulations Grows

Lack of predictability uncertainty over fees and inefficient working practices inherent in the current implementation of EU rules are all demanding a rethink in the EU’s current and future medtech rules. Industry expects discussions to kick off early next year.

Fuzzy man walking on hanging bridge vanishing in fog. Focus on middle of bridge
Waiting For The Mists To Clear On Way Forward For EU's Medtech Regulation • Source: Shutterstock

Action is essential, both mid-term and more immediately, to improve the implementation of the EU’s medtech regulations and to find a better way forward as the “EU is not where it should be.”

That is the view of Petra Zoellner, director regulatory affairs (IVDR and MDR) at MedTech Europe while speaking with Medtech...

More from Europe

Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 

Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

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.

More from Geography

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

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.