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

Expertise

Latest expertise on medical device regulation in our blog

about 100000 Words in the European Regulation on Medical Devices (MDR)
904.81555555556 Days until the end of the MDR transition period
more than 200 relevant medical device standards
more than 100 MDCG guidances and other relevant recommendations

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.

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.