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Medical Devices Regulation in Europe MDR EU/2017/745
Training Course
Course Details
Event Scheduled: On request Learning Mode: Online Language: English (see more details below)
Learning Objectives
Understand the main requirements on the European regulation of medical devices and the ongoing changes from the Directives approach
Acquire skills on the application of the main requirements of the Medical Devices Regulation EU/2017/745
Understand the main changes from the regulatory framework described by the European Directives (Directive 93/42/EEC), the current status and the impact on Manufacturers
Who will benefit?
Quality Management and Regulatory Affairs Managers in organisations operating in the medical sector. The course is also intended for organisations operating as distributors, importers and Authorized Representatives.
Course Agenda
Introduction
Current regulatory framework
Definitions
European and national legislation on medical devices
Status of Regulations
Publication of MDR Regulations EU/2017/745 on medical devices and IVDR Regulations EU/2017/746 on in vitro diagnostic devices
Reference documents
Medical Device Regulation: key aspects
The changed regulatory framework compared to the European directives
The new ‘actors’ to whom the Regulations apply: manufacturers, importing distributors, Authorized Representatives
Structure of the MDR Regulation EU/2017/745
Main contents in detail
Main differences from the regulatory situation described by 93/42/EEC
Some key focuses in the MDR regulation
New ‘actors’: impact on current activities
Clinical Evaluation: What changes?
Post Market Surveillance and Supervision
Traceability
Technical Documentation
Classification
Transition Management and the Impact on Existing CE Certifications
Prerequisites
As this is an advanced course, a thorough knowledge of the European directives in the field of medical devices (MDD 93/42/EEC and subsequent updates) is required.
Learning Assessments
Upon completion, you will receive your globally recognised TÜV SÜD certificate of attendance on "The Medical Devices Regulation in Europe MDR EU/2017/745" training course.
Teaching Materials
Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.
Learning Assessments
Certificate of competence, in case of successful completion of final exam
Certificate of attendance, in case of non successful completion of final exam or no exam
Duration
1 Day (8 hours).
Scheduled Events
Events will be planned on request (and published on this page).
Price
610,00 € (per participant, taxation excl.)
Learning Mode
Online, Instructor-Led. The course is held by a qualified TÜV Italia Akademie trainer.
