Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it is only the beginning. In this episode, Osman El-Koubani shares insights into the post-market realities of AI as a Medical Device (SaMD) and what manufacturers must do to remain compliant over time. CE Certification Is Not the Finish Line Many companies assume that once their device is certified, the main regulatory burden is over. In reality, Post-Market Surveillance (PMS) becomes critical — especially for AI systems that can evolve or degrade in real-world conditions. Relaxing after certification can lead to:• Loss of control over performance• Undetected risks• Regulatory non-compliance AI in the Real World: Performance Drift AI models often behave differently once exposed to real-world data. This phenomenon, known as performance drift, can reduce accuracy and reliability over time. Manufacturers must implement continuous monitoring strategies, including:• Real-world data (RWD) collection• Performance tracking• Feedback loops for improvement Updating AI Devices: What Is Allowed? Updating AI systems introduces regulatory complexity. Key questions include:• What qualifies as a significant change?• Does retraining require re-certification?• How should updates be documented and justified? Manufacturers often struggle with these decisions, leading to compliance risks. PCCP: Enabling Controlled Evolution The concept of a Predetermined Change Control Plan (PCCP) allows manufacturers to define in advance how an AI system can evolve. While this concept is gaining traction globally, its implementation in Europe is still evolving and requires careful regulatory consideration. Building a Mature AI PMS System A robust post-market system for AI devices should include:• Continuous performance monitoring• Risk management integration• Clear documentation of updates• Strong governance of data and models Who is Osman El-Koubani Dr Osman El-Koubani is a doctor and clinical researcher. With nearly a decade of experience at the intersection of healthcare, digital innovation, and AI, he has developed and implemented NHS digital solutions and advised multiple software and AI medical device startups. At Scarlet, Osman works as a Clinical Engineer and AI/ML expert, leading clinical evaluation, risk management, and usability for AI-driven medical devices, while also helping SaMD and AIaMD manufacturers navigate certification and maintain compliance through transparent, practical, and safety-focused regulatory processes. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well. Link Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=true Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
