Training
Training on Medical Devices Regulation (EU) 2017/745
THE CONTEXT OF THE TRAINING
The European Medical Devices Regulation (EU) 2017/745 (MDR) has been effective since May 26, 2021, repealing and replacing the European medical device council directive (93-42/EEC). This recent regulation applies to any new medical device (MD) introduced on the market or a major modification of a MD already present on the European market and/or medical devices companies. This regulation refers to the requirement of the ISO 13485 standard related to medical devices.
TRAINING OBJECTIVES
- Gain a complete overview of the requirements of the new medical devices regulation 2017/745;
- Identify the key changes in the transition from the former medical devices directive to the new regulation ;
- Understand the impact of the regulation on your organization, your QMS (Quality Management System), and your medical devices manufacturing;
- Get an overview of the regulatory changes including the Algerian regulation;
- Build a transition plan to comply with the current regulations.
WHO IS CONCERNED BY THIS TRAINING ?
- Quality assurance staff;
- Agents of MD (Medical Devices);
- Medical device distribution and supply managers;
- Regulatory affairs managers and officers;
- Manufacturers and producers of medical devices;
- Medical devices repair companies;
- Medical devices maintenance companies;
- Suppliers of raw materials and services used in the production of medical devices.
PREREQUISITES
- Knowledge in medical device regulations ;
- Basic knowledge in the ISO 13485:2016 standard ;
- Being concerned by the training.
COURSE OF THE TRAINING
The training on Medical Devices Regulation (EU) 2017/745 will last 1 day and aims at orienting the participants on the European Regulation (EU) 2017/745 (MDR) recently put into force.
During this session, the participants will be provided with the necessary learning materials, as well as a certificate delivered at the end of the training.