MDR, IVDR, and the AI Act: What They Mean for Software as a Medical Device

In this webinar, we will begin with an expert-led overview of the current MDR landscape, presented by the Medical Device Working Group.
The regulatory landscape for medical devices (MDs) and in vitro diagnostics (IVDs) devices in Europe has undergone significant changes with the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). These regulations were designed to enhance safety, transparency, and innovation by creating a more robust, transparent, predictable and sustainable system.
Two EU Regulations IVD Regulation 2017/746/EU (IVDR) and Medical Devices Regulation 2017/745/EU (MDR) were published in May 2017 governing the safety and performance of devices across their lifetime.
Under these EU Regulations medical devices or diagnostics in Europe must go through an evaluation process called a ‘conformity assessment’. This process ensures that products placed on the market are compliant with the regulatory rules and presents more benefits than risks. The level of oversight depends on the risk class of the product: the higher the risk, the stricter the checks.
Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device.

Subsequently, we will explore the rapidly evolving landscape of Software as a Medical Device (SaMD), focusing on how the EU MDR and the upcoming AI Act are reshaping compliance, innovation, and commercialization strategies. Drawing from real-world experience with Healthentia – one of the first SaMD apps in Europe certified under MDR Class IIa – we will highlight both the opportunities created by regulatory clarity and the operational challenges that manufacturers face when integrating AI-driven functionalities. Key topics will include navigating dual compliance (MDR & AI Act), balancing safety with agility, and strategies for separating medical-grade and wellbeing features to enable faster scaling. Participants will gain practical insights into building future-proof SaMD solutions that are both regulatory-compliant and business-viable.