Medical Devices
and Software

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.