Medical Devices Regulations - English

• 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)

• 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.

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 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).

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

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.

Participants will learn through role plays, case studies, group exercises, scenarios and discussions. 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.