Understand the requirements of Medical Device Regulation (MDR)
Understand the requirements of Medical Device Regulation (MDR)
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.
Duration: 1 - day course
Topics to be covered in this course include:
• 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
Participants will learn through lectures, case studies, group exercises and discussions.
This course is suitable for Medical Device professionals that are in areas such as:
Prerequisite: None
The course content and structure are designed by the domain experts from TÜV SÜD Malaysia and global
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.
World-class training – by learning from TÜV SÜD’s industry experts and training specialists
Interactive learning style – with interactive formats such as lectures, illustrations and simulations are used
Networking opportunity – where you can meet and build network with like-minded individuals at our instructor-led training
Gain a competitive edge – by getting trained by experts known in the fields of safety, security and sustainability
To enroll, please fill out the form on the webpage accordingly.
Participants will learn through role plays, case studies, group exercises, scenarios and discussions.
There are no in-between assessments, but case studies will be included in the Introducing Medical Device Regulation course.
Yes, please contact us at [email protected] for more details. Terms and conditions apply.
Yes, you can register to any e-learning courses. If you have special requirements, please contact us at [email protected] and we can customise a suitable package for you.
Yes, you will receive a certificate of completion at the end of the Introducing Medical Device Regulation course.
The Introducing Medical Device Regulation 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 Introducing Medical Device Regulation course content based on current business landscape and market requirements. The experts also undergo relevant upskilling programmes, benefitting from TÜV SÜD’s 150 years of expertise and global heritage.
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