Good Management of Medical Devices including In Vitro Diagnostics and Companion Diagnostics: Legal and practical aspects of devices

The course will give clear, practical guidelines on how to develop a medical device and how to identify the correct development path.

Part One: Philosophy and Legislation
Part One will deliver the knowledge base for the subsequent parts. It will give an overview of the EU device legislative system and the principles and philosophy behind it. It will explain the definition of a medical device and the demarcation between medical devices and pharmaceuticals. It will also explain risk classification of medical devices and the relationship between risk classification and conformity assessment procedures. This first part will highlight the role of the notified bodies and the legal basis for the requirements for clinical evaluation and clinical investigation. Also, the regulatory route for different types of combination products will be explained. A comparison of the EU and US regulatory systems will conclude this part.

Part Two: Operational Aspects I - Clinical and Vigilance
For medical devices that need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be explained. The practical differences between the clinical development of pharmaceuticals and medical devices will be explored and the challenge of developing a drug device combination product will be touched upon. Responsibilities in post-marketing surveillance of medical devices (and drug device combination products) according to the Medical Device Vigilance System will be explained and illustrated with examples.

Part Three: Operational Aspects II - Quality Management, Risk Management, and Design Dossier
Part Three will start with the ins and outs of working with notified bodies. It will continue with the application of quality management and risk management to the development of medical devices, including the discussion of applicable ISO-standards. Differences between risk management of medical devices and pharmaceutical products will be pointed out. Furthermore, the process of ‘constructing’ a design dossier will be highlighted, both for medical devices and for combination products.

• Medical device regulation: philosophy, content and structure
• Risk-classification of medical devices
• Drug-device combination products
• CE mark
• ISO 14155
• 93/42/EC, as amended by 2007/47/EC
• Clinical evaluation and clinical investigation
• Medical devices vigilance system
• In Vitro Diagnostics (IVD)
• Difference between IVD and personalised medicine

This course is designed for professionals starting work in industry and regulatory bodies, who would like to get acquainted quickly with all aspects of medical device regulation.

This course is also aimed at professionals in pharmaceuticals (e.g. regulatory affairs, clinical development), who would like to obtain an overview of device regulation, or who are involved in either drug-device combinations or medical devices.

Participants are expected to have a relevant master’s degree or to be working in pharmaceuticals or in medical devices.

At the conclusion of this course, participants should be able to:

• Apply the principles of medical device regulation
• Classify medical devices according to rules for risk classification
• Identify the applicable conformity assessment procedure
• Understand the issues surrounding combination products (including ATMPs)
• Conduct a medical device trial according to ISO14155
• Understand ethical and regulatory considerations of medical device trials
• Understand the practical differences between medical device and drug development
• Identify responsibilities in post-marketing surveillance
• Evaluate risks and handle incident reports
• Apply the principles of the IVD directive
• Understand the difference in lifecycle of an IVD and personalised medicine