NDA Group - an SSI Strategy Company published draft guidelines from the European Commission clarifying how AI systems are classified as high-risk under the AI Act, including systems used in or constituting medical devices.

NDA Group is the regulatory powerhouse of SSI Strategy. For more than 25 years we’ve leveraged our extensive experience and global network to help you optimize your regulatory strategies, expedite filings, and secure successful approvals in key markets worldwide. By integrating our regulatory proficiency with SSI Strategy's strategic capabilities in clinical development, medical affairs and commercial planning, we provide biotech companies with a holistic solution that maximizes the value of their assets and ensures timely access to innovative therapies. We understand that bringing a new therapy to market is a complex and challenging endeavor, and we are committed to providing the expertise, insights, and support needed to help you achieve your company vision. Whether you are a startup biotech looking to optimize your development strategy, or an established player seeking to expand into new markets, we have the knowledge, network, and experience to help you succeed. Partner with us to unlock the full potential of your innovations and bring life-changing therapies to patients without unnecessary delays.