EU MedTech Forum 2022: Regulatory Unpredictability Spurs Renewed Calls For Devices Agency

In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been a factor in calls for a devices agency. MedTech Europe’s Oliver Bisazza and BVMed’s Marc Pierre Möll reviewed the top concerns aired at the MedTech Forum in early May.

Business questions (TierneyMJ/Shutterstock.com)

Despite the implementation date of the IVD Regulation looming on 26 May and the Medical Device Regulation having been applicable for nearly a year now, there are many key uncertainties surrounding the implementation of both regulations.

The current unpredictability within the system has industry seeking urgent answers. So it was hardly surprising that the two sessions...

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

Start Free Trial

Already a subscriber?

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

11 Jul 2025

• By Amanda Maxwell

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

10 Jul 2025

• By Natasha Barrow

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

10 Jul 2025

• By Amanda Maxwell

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

09 Jul 2025

• By Brian Bossetta

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.