Choose another country to see content specific to your location

//Select Country

Introduction to EU Regulations for Medical Devices

Get an overview of the European Regulations replacing AIMD, MDD & IVDD

ABOUT THE INTRODUCTION TO EU REGULATIONS FOR MEDICAL DEVICES COURSE

This paid training course will provide an introduction into both Medical Device Regulation (MDR) & In-vitro Diagnostic Device Regulation (IVDR).

Medical Device Regulation Training (MDR Training)

The European Union’s Medical Devices Regulation (MDR 2017/745/EU) replacing Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMD 90/385/EEC) was officially published on 5 May 2017 and came into force on 25 May 2017. MDR applies from 26 May 2020 after a transition period of three years. 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 emphasises 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.

In-vitro Diagnostic Device Regulation Training (IVDR Training)

This 0.5-day IVDR paid training course will provide a brief overview of the European Regulation 2017/746 related to in vitro Diagnostic Devices.

IVDR will replace the EU's current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.

Manufacturers of currently approved in vitro diagnostic medical devices will have a transition time of five years, up to May 26, 2022 to meet the requirements of the IVDR. Products already certified by a Notified Body may be placed on the market for further 2 years under the following conditions: 1) The certificate issued under the IVDD is still valid; 2) The device continues to comply with the directive and 3) No significant changes in design and intended purpose

Manufacturers of in vitro diagnostic medical devices are well-advised to stay current on amendments to IVDR by training and retraining staff over the next few years. Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. There are no grandfathering provisions, so it is time to help your organization understand this regulation.

Duration: 2 - day course

WHAT WILL YOU LEARN FROM EU REGULATIONS FOR MEDICAL DEVICES COURSE?

The objectives of this course are:

Identify the changes introduced by the regulation
Appraise processes and structural impacts of the regulation on their organisation
Develop strategies to answer new requirements and prepare a smooth transition

Topics to be covered in this course include:

Day 1: Medical Device Regulation (MDR) Training – Morning & Afternoon session

Day 2: Medical Device Regulation (MDR) Training – Morning session
• 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

Day 2: In-vitro Diagnostic Device Regulation (IVDR) – Afternoon Session 
• IVD Directive (IVDD) and Regulation (IVDR)
• Requirements for economic operators
• Classification of IVD medical devices (IVDD vs IVDR)
• Conformity assessment procedures
• Post-Market Surveillance, vigilance and market surveillance requirements
• IVDD to IVDR Transition Timeline

WHAT IS THE EU REGULATIONS FOR MEDICAL DEVICES COURSE METHODOLOGY?

Participants will learn through lectures and discussions.

WHO SHOULD TAKE THE EU REGULATIONS FOR MEDICAL DEVICES COURSE COURSE?

This paid training course is specially designed for:

Newcomers in the medical device industry
Expert and executive personnel to update their knowledge
Personnel in charge of regulatory affairs
Personnel in quality management
Consultants in the medical device industry

Prerequisite: None

WHO IS THE EU REGULATIONS FOR MEDICAL DEVICES COURSE ADVISOR?

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.

  • WHAT ARE THE BENEFITS OF ENROLLING IN THIS COURSE?
    • 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

  • FAQs
    1. How do I enroll for the course?
      To enroll, please fill up the form on this page accordingly.
    2. Can I get a refund if I cancel my enrollment?
      Yes, please contact us at [email protected] for more details. Terms and conditions apply.
    3. Can I also attend E-learning courses on top of attending the instructor-led course?
      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.
    4. Upon completion of the course, would I get a certificate for completion?
      Yes, you will receive a certificate of completion at the end of the course.
    5. Who developed the course and what are their qualifications?
      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. The experts also undergo relevant upskilling programmes, benefitting from TÜV SÜD’s 150 years of expertise and global heritage.

    To know more about TÜV SÜD, please click here.

Next Steps

Select Your Location

Global

Americas

Asia

Europe

Middle East and Africa