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MDR In Detail Training Course

Face to face Training1 DayBeginnerVirtual Classroom

All manufacturers of Class I to III medical products must familiarise 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 organisation goals. The scrutiny procedure, reprocessing requirements, and the introduction of the European database Eudamed also bring about profound changes.

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

Course Testimonial: "Great presentation style which was very interactive. Guided by the questions from the trainees, the trainer provided a lot of very useful information through links to websites that would provide further information."

  • Regulatory affairs managers
  • Quality managers
  • Heads of research & development
  • Importers
  • Distributors and medical device advisors
  • EU regulatory officials and staff in surveillance authorities
  • Consultants and other service providers.
  • 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.

  • 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)
  • Course delivered by one of TÜV SÜD's leading industry experts
  • Small class sizes enhance trainer-delegate relationship
  • Receive globally recognised TÜV SÜD certificate upon completion

Upon completion you will receive your globally recognised TÜV SÜD certificate on MDR in detail.

TÜV SÜD additionally offers the opportunity to deliver this training as a dedicated in-house course, delivered solely to your organisation to meet your needs and requirements. To receive a quote and find out more information, please contact us at [email protected].

Net Price (excl. VAT)
from£ 699.00

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Book training course MDR In Detail Training Course
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From 08/07/24
Virtual Classroom
£ 699.00 add. VAT

Course No.
1882

Duration
1 Day

Show Agenda

Location
Virtual Classroom

Price

Net Price
£ 699.00
plus VAT:
£ 139.80

Total Price (inc. VAT)
£ 838.80

Course No.
1884

Duration
1 Day

Show Agenda

Location
Virtual Classroom

Price

Net Price
£ 699.00
plus VAT:
£ 139.80

Total Price (inc. VAT)
£ 838.80

Course No.
1886

Duration
1 Day

Show Agenda

Location
Virtual Classroom

Price

Net Price
£ 699.00
plus VAT:
£ 139.80

Total Price (inc. VAT)
£ 838.80