An Introduction to the Medical Device RegulationManagement Forum
An Introduction to the Medical Device Regulation
This seminar provides a detailed introduction to the European Medical Device Regulation (MDR). It will explain the new legislation and which products are covered, the involvement of Notified Bodies and how to choose one and will outline a manufacturer’s responsibilities. It will also cover the documentation necessary to apply for the CE mark.
This is an excellent introduction from leading experts in the field and delegates should expect three comprehensive days of training.
For a more advanced follow-on course from this, please see our Advanced Regulatory Affairs for Medical Devices which you may also be interested in.
Who Should Attend
Past delegates include personnel from regulatory affairs, pharmacovigilance, quality assurance and technical support. This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
Programme Day One
What is a medical device?
Europe and the MDR – overview of the regulations applicable for bringing a medical device to market
Economic operators and other parties
- Who are they?
- How do they interrelate?
- What are their responsibilities?
Classification of devices
- What are the classes and how do we classify devices?
Conformity assessment procedures
- The routes to CE marking
- What is required for each class of device?
Workshop 1: Classification
Programme Day Two
- Technical file and design dossier requirements
- EN ISO 13485: 2012 and 2016
- The requirements for a quality system
Labelling of devices
- Use of language and symbols
- Instructions for use
Workshop 2: Labelling
- European regulatory environment
- When are clinical investigations necessary?
- What is required by the Competent Authority, Ethics Committee and Notified Body?
Workshop 3: CE marking 16.45 u Discussion session
Programme Day Three
Medical device vigilance
- Adverse event reporting
- Reporting requirements
- Post-market surveillance (PMS)
Workshop 4: Vigilance
- Drug or device?
- Examples of classification
Devices incorporating material of animal origin
- Animal-derived materials legislation
- Directive 2003/32/EC
The revision to the regulations for medical devices
Question and answer session
Provider: Management Forum
Management Forum - Professional training courses for the Life Sciences and Intellectual Property Sectors
Management Forum is an internationally renowned training provider organising professional conferences, seminars and in-house courses for professionals and companies in the Life Sciences and Intellectual Property sectors. With their growing programme portfolio, training specialists at Management Forum aim to provide...
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