Navigate the complexities of software classification under the Medical Device Regulation, to ensure compliance and avoid regulatory pitfalls. Attend this course to gain expert insights, so that you can confidently apply the MDCG guidelines and enhance your approach to medical device software classification.
Join us for an insightful course delving into the complexities of software classification under the Medical Device Regulations. With the flawed Classification Rule 11 you need expert advice to navigate this opaque topic effectively. This course, led by a key participant in the drafting process of the Medical Device Coordinators Group (MDCG) guidance, provides invaluable context to help you read between the lines and understand the true intent behind its wording. Don’t let the convoluted language and cautious interpretations by regulators trip you up.
The course includes comprehensive case studies to solidify your understanding, allowing you to apply what you've learned to real-world scenarios. From our expert course leader's insider perspective, you will get a clear interpretation of the MDCG guidelines, ensuring you are well-prepared to navigate and apply them in your work.
We will also explore the Helsinki Procedure, a crucial framework for resolving disputes and providing guidance on challenging classification issues.
Benefits of attending
By attending this course, you will:
- Examine the implementation and classification rules
- Understand what is behind the convoluted MDCG language
- Master the key concepts to classify medical device software
- Learn how to apply the classification rules to real-world examples
- Explore your options when faced with a disagreeing notified body or unfair competition
Certifications:
- CPD: 3 hours for your records
- Certificate of completion
Course Content
Classification of Medical Device Software
- Implementing rules
- Classification rules
- Software that drives or influences the use of a (hardware) medical device
- Classification rule 11
- International Medical Device Regulators Forum (IMDRF) SaMD risk type determination
- International Medical Device Regulators Forum (IMDRF) SaMD risk stratification framework and its pitfalls
- Classification rules 13, 15, and 22
Case studies - Classification
Borderline cases
- Borderline manual on qualification and classification
- Helsinki procedure
- Dispute resolution and fair competition
Course Provider
Koen Cobbaert,
Philips HealthcareKoen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the IMDRF on matters related to software and artificial intelligence. He also contributes to various standardisation organizations focusing on software and artificial intelligence.
In the legislative domain, Koen chairs COCIR’s and DITTA’s software focus groups, representing its members at respectively the European Commission MDCG workgroups on Borderline and Classification and New Technologies and at the international level at the International Medical Device Regulators Forum (IMDRF) workgroup on artificial intelligence. Koen is also an advisor in the SaMD workgroup at the Global Harmonization Working Party (GHWP). Currently, Koen is engaged in various proposed EU legislation relating to artificial intelligence and data (AI Act, Machinery Regulation, General Product Safety Directive, Data Act, European Health Data Space…). Aside from various publications through trade associations, Koen also edited the book In the standardization domain, Koen is a member of CEN-CENELEC’s Industry Advisory Forum, and he is delegated as a Belgian expert to IEC JTC 1 SC 42 on artificial intelligence, CEN-CENELEC JTC21 on artificial intelligence, ISO TC215 JWG7 on health informatics, and to the IEC SC62A Advisory group on Software, Networks, and Artificial Intelligence (SNAIG).
Koen has a Master of Science in electrical engineering and safety risk management. He has over 15 years of hands-on experience establishing regulatory and market-access strategies for medical device software, performing worldwide regulatory submissions, and moderating risk management and clinical evaluation for software applications for general radiology, oncology, neurology, cardiology, orthopaedics, and clinical pathology. He has worked on software applications for pattern recognition, computer-aided detection, reasoning engines, clinical pathways, and other clinical decision support systems, including mobile apps, embedded software, and software operating in the cloud.
Who Should Attend
Any professionals that are integral in navigating and applying the complex classification rules for software as a medical device (SaMD) or medical device software (MDSW) under the current regulations, including:
- Regulatory affairs specialists
- Legal professionals in the medical device industry
