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:
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.
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Bosnia and Herzegovina