The course will give clear, practical guidelines on how to develop a medical device and how to identify the correct development path.
Day One: Philosophy, Legislation and Post-Marketing Obligations
Day one will start with 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 the essential features of medical device regulation, such as essential requirements, risk classification, the relationship between risk classification and conformity assessment procedures and the role of notified bodies.
The second part will focus on post-market responsibilities such as vigilance (according to the Medical Device Vigilance System) and post-market surveillance and will be illustrated with practical examples.
Day Two: Clinical, Combination Products and Future Changes
Day two will start with the legal obligations for clinical evaluation and clinical investigation. 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. Also, the regulatory routes for different types of combination products will be explained and the challenge of developing a drug device combination product will be touched upon.
The potential consequences of the upcoming Revision of the Medical Device Directives will be highlighted. A comparison of the EU and US regulatory systems will conclude this day.
Day Three: Notified Bodies, Quality Management, Risk Management, and Design Dossier
Day 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. The changes in the role of notified bodies, which are due to recent legal changes, will be explained. The day will be concluded by a general exercise.
What You Will Learn
- Medical device regulation: philosophy, content and structure
- 93/42/EC, as amended by 2007/47/EC
- CE mark
- ISO 14155, ISO 13485 and ISO 14791
- Risk-classification of medical devices
- Drug-device combination products
- Clinical evaluation and clinical investigation
- Medical devices vigilance system
- Recent and upcoming legal changes
Who Should Attend
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 ISO 14155
- 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
There will be an assessment at the end of the course: 60 multiple choice questions, 45 minutes
Back-to-back Training Courses
Register online for Good Management of Medical Devices, ID#14536, and EU Regulation of IVDs, ID#14538
AND SAVE UP TO EUR 100!
Hotel & Travel
This course will take place at:
Hotel NH Musica
van Leijenberghlaan 221
1082 GG Amsterdam
Tel: +31 20 79 56 088
DIA has blocked a limited number of rooms at the rate of EUR 122.00 per room/night, including VAT, excluding breakfast. To make the reservation, please click here.
Important: The room rate is available until 12 May 2014 or until the group block is sold-out, whichever comes first.
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52