Standards are documents that describe technical requirements for products or process requirements in a formal manner with the aim of achieving high levels of safety, security, quality and compatibility.
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- Medical Device Clinical InvestigationsMedical device clinical trials are completely new regulated under the EU MDR. Manufacturers are faced with new challenges.
- Efficient market access for artificial intelligence (AI)-based software: BAIMProvided 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”. In this blog post we explain the respective background.
- EU Regulatory Affairs and Liability Risks of AI-based Medical DevicesManufacturers of medical devices based on artificial intelligence (AI) technologies are facing two major regulatory challenges in Europe: The fulfillment of the fundamental regulatory requirements for medical devices focusing on software and the Integration of special requirements for AI-based devices into the quality management system.
- 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.
- NB's New Requirements for AI-based SoftwareNotified Bodies have published a question catalog for medical devices with AI-based software. To meet the requirements, manufacturers should complement their processes.