Artificial Intelligence (AI) is an emerging and promising field, especially for healthcare applications. For the development AI applications in health, it is important to consider the rules and regulations that apply to your future MedTech product, which are evolving too.
Some key considerations are the recently published (2021) harmonized rules for AI in the EU, and the Medical Device Regulation (EU-MDR, 2017/465), which came into effect earlier this year.
MedTech AI applications in AI are considered high-risk, if they are part of Medical Devices or In-vitro Diagnostics, which are subject to conformity assessment by a third party (a Notified Body such as BSI or Dekra). This means that Artificial Intelligence components of a Medical Device are considered high risk if this device is classified as IIa or higher and for In-Vitro Diagnostics as Class B or higher.
In the US the FDA has introduced an array of specific codes under federal regulations (21CFR) for software applications, which act as Clinical Decision Support Systems , and which reflect the increasing complexity of such software applications. Additionally, the FDA recently developed a framework for Artificial Intelligence/Machine Learning, and action plan with five focus areas to better evaluate AI & Software applications.
In general, in the process of getting your Medical Device to market, the earlier you can establish a clear view on the rules and risks for your application in the development process, of the better you can enlist the right clinical evidence and documentation for market compliance right from the start. It is also key to understand that seemingly small decisions in you product definition and development process may have large effects on the clinical data required, or the regulatory pathway to market access.
MD squared helps start-up and scale-up companies in this area to advance their business with an integral view on Growing MedTech Together. Our team of international and seasoned experts are there to support you with your Regulatory approach, Clinical Data, Development and Manufacturing, Quality and Documentation, Product, Markets & Business strategy.
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