The course will give a clear guide how to develop practically a medical device and how to identify the correct development path.
Day One: Philosophy and Legislation
Day One will deliver the knowledge base for the subsequent days. 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 relation between risk classification and conformity assessment procedures. The first day 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 day I.
Day Two: Operational Aspects I - Clinical and Vigilance
For medical devices which need to be tested clinically, the process of planning, conducting and reporting a clinical investigation with medical devices will be explained to the course attendees.
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.
In the afternoon, 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.
Day Three: Operational Aspects II - Quality Management, Risk Management, Design Dossier and Wrap-up
Day Three will start with the ins and outs of working with notified bodies. The day 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.
Day Three will conclude with a ´wrap-up’ session, in which the elements of the previous sessions will be integrated.
Day Four: In Vitro Diagnostics and Companion Diagnostics – Legal and Practical Aspects as used in Personalised Medicine
• 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