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About the course
The European Union’s Medical Devices Regulation (MDR 2017/745/EU) was officially published on 5 May 2017 and came into force on 25 May 2017. It will eventually replace the Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMD 90/385/EEC). Manufacturers of currently approved medical devices under MDD and AIMD will have a transition time of three years until 26 May 2020 to meet the requirements of the MDR. For certain devices, this transition can be extended until 26 May 2024.
The MDR introduces numerous changes, including shift from pre-approval stage to life-cycle approach. It also incorporates European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluation and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers.
What will you learn from the course?
Through this course, you will gain insights on the requirements of the MDR to better prepare your organization and your medical devices to transition smoothly to the MDR to continue to affix CE marking to your devices.
- Introduction to MDR
- Classification of medical devices
- Conformity assessment procedure
- Technical documentation requirement
- General Safety and Performance Requirements
- Clinical data & clinical evaluation requirements
- Post-Market Surveillance, vigilance and market surveillance requirements
What is the course methodology?
Participants will learn through lectures, case studies, group exercises and discussions.
Who should take the course?
This course is suitable to Medical Device professionals that are in areas such as quality, risk management, R&D, manufacturing, etc, or anyone who work in Medical Device sector that market products to EU.
Who is the course advisor?
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
What are the benefits of enrolling in this course?
- World-Class Training
Learn from TÜV SÜD’s industry expert and training specialist
- Interactive Learning Style
Interactive formats such as lectures, illustrations and simulations are used
- Networking Opportunity
Meet and build network with like-minded individuals at our instructor-led training
- Gain A Competitive Edge
Gain knowledge and develop relevant skills to stay relevant
Contact us for enquiries
To contact someone from TÜV SÜD, you may email us at firstname.lastname@example.org or call +65 6885 1667.
To know more about TÜV SÜD, please click here.
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