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Medical Device Regulation (MDR)

Instructor-led Training1 DayBeginnerVirtual Classroom

In this training course:

  • The new legal requirements of the Medical Device Regulation (MDR) will be provided to you in a compact form.
  • You will receive an overview of the efficient and safe manufacture of medical products in accordance with the Medical Device Regulation (MDR).
  • You will gain an understanding of your responsibilities and obligations as a manufacturer, EU representatives, importers and distributers of medical devices Class I to III.

This course is suitable for medical device manufacturers and professionals that are in areas such as:

  • Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality & Risk Management, R&D, Manufacturing, and Quality Assurance personnel
  • Expert and executive personnel to update their knowledge
  • Consultants in the medical device industry
  • Newcomers in the medical device industry
  • Anyone who is working in the Medical Device sector that market products to the EU
  • Contents and Fundamentals of the Medical Device Regulation (MDR)
  • Classification/Reclassification of Products
  • Non-Medical Products within the Scope of the Medical Device Regulation (MDR)
  • Common Technical Specifications
  • New Basic Requirements
  • Content Requirements for Technical Documentation
  • Post Market Surveillance
  • Scrutiny Procedure
  • Validity of Conformity Assessment and Certification, Transition Periods
  • Requirements for Different Actors, e. g.:
    • Manufacturers
    • Importers
    • EU Representatives
    • Distributors and Service Partners
  • Role of Person Responsible for Regulatory Compliance (PRRC)
  • Eudamed Database
  • UDI (Unique Device Identification)

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 to meet the requirements of the MDR. For certain devices, this transition can be extended as follows.

The transition period for the Medical Device Regulation (MDR) has been extended. Here are the key points:
  1. Class III Implantable Custom-Made Devices:
    • The transition deadline for these devices has been extended to 26 May 2026.
    • This means that manufacturers of Class III implantable custom-made devices have more time to comply with the MDR requirements.
  2. Class III and Implantable Class IIb Devices:
    • The new deadline for these devices to transition to the MDR is 31 December 2007.
  3. Non-Implantable Class IIb and Lowr Risk Devices:
    • For these devices, the transition deadline is 31 December 2028.
Remember that these extensions provide additional time for manufacturers to adapt to the new regulations and ensure the safety and effectiveness of medical devices in the European market.

The new regulation will have a great impact on all medical device actors, throughout the lifecycle of the devices, with stricter requirements on both products and on manufacturers’ Quality Management Systems. 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.

All manufacturers of Class I to III medical products must familiarize themselves with the requirements of the Medical Device Regulation (EU) 2017/745 (MDR). The regulation has far-reaching implications and affects all classes of medical products. Products that are not medical products as such are regulated by the Medical Device Regulation (MDR). Among the aspects changed are the classification of products, previous basic requirements, technical documentation, clinical evidence, market surveillance, and quality management systems. The European approval process is uniformly regulated and entails significant changes in terms of organization goals. The scrutiny procedure, reprocessing requirements, and the introduction of the European database Eudamed also bring about profound changes.

In our one-day seminar, you will gain a compact overview to align your company with the requirements of the Medical Device Regulation (MDR).

  • 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 medical devices.

Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.

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.

Please bring a copy of the MDR with you to the course. A free copy can be downloaded from the EUR-Lex European Union law website.Participants will receive a Certificate of Attendance from TÜV SÜD Academy.
Price (excl. TAX)
from$ 995.00

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From 14.Aug.2024
Online
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$ 995.00 excl. TAX

Event No.
3465

Duration
1 Day

Show Schedule

Location
Online

Price

Net price
$ 995.00
0% TAX
$ 0.00

Price (excl. TAX):
$ 995.00

Event No.
3467

Duration
1 Day

Show Schedule

Location
Online

Price

Net price
$ 995.00
0% TAX
$ 0.00

Price (excl. TAX):
$ 995.00

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