INTRODUCING MEDICAL DEVICE REGULATION TRAINING

Understand the requirements of Medical Device Regulation (MDR)

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.

Duration: 1 - day course

WHAT WILL YOU LEARN FROM THE 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

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.

Prerequisite: None

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.

Next Steps