Medical Devices
and Software

VDE offers hands-on support for the approval and certification of medical devices and software.
Get your product to market faster.

Consulting

Practical support for the approval and certification of medical devices

Coaching

Hands-on workshops on all aspects of market access for medical devices

Know-How

Latest expertise on medical device regulation in our blog

98000 Words in MDR (EU) 2017/745
1268.0069212963 Days until the end of MDR transition period
> 230 Medical Device Standards
60 + XEC Guidances and Specifications

Efficient market access for artificial intelligence (AI)-based software: BAIM

Provided that an AI-based software has a medical intended purpose, it is subject to the regulations 2017/745 (MDR) or 2017/746 (IVDR) in the EU. To help manufacturers of AI-based software in medicine dealing with the ever-increasing stringent requirements for market access, the VDE has developed the regulatory approach “BAIM – Boost AI to Market”.

CE roadmap for medical devices

What are the requirements for approval and what are the costs?

Every time a medical device is developed, the question comes up at some point which regulatory requirements have to be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e. the requirements of the European Medical Device Regulation (MDR) apply.

627 FDA Software Recalls (2011-2015)
> 400 CFR 21 Parts
> 1400 Recognised Consensus Standards
622 FDA Medical Device Guidances

Medical Apps or Software

Classification and Approval as Medical Device

Software like a medical app that has a medical purpose is legally a medical device.

Testing and Certification

of medical devices and software

The VDE Institute helps you comply with the regulatory guidelines and obtain internationally recognized certifications.