4611092-EN

Medical Device Regulation (MDR) in Detail - English

Instructor-led Training1 dayBeginner
All manufacturers of Class I to III medical products must familiarize themselves with the requirements of the Medical Device Regulation (EU) 2017/745 (MDR) as soon as possible. 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).
  • 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 für Regulatory Compliance (PRRC)
  • Eudamed Database
  • UDI (Unique Device Identification)
  • The 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.
  • 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
  • As a participant, you will receive an edition of the pocketbock Medical Device Regulation (MDR).
  • This seminar is offered as a basic module of modular further education. After successful participation in the advanced modules, you can obtain the recognized degree as MDR-Expert TÜV.
Nettopreis (zzgl. MwSt.)
1.000,00 CHF

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