EU Medical Devices Regulation 745/2017
The following contents from Medical Device Regulation (MDR) are covered by the training in Slovenian language which includes practical samples:
- Scope and definitions
- Placing on the market and putting into service or use
- Usage of harmonized standards
- General obligations of manufacturers, importers and distributors
- Authorized representative
- Person responsible for regulatory compliance
- Single-use devices and their reprocessing
- EU declaration of conformity and CE marking of conformity
- Systems and procedure packs
- Unique device identification system
- UDI database
- Registration of devices
- Summary of safety and clinical performance
- Registration of manufacturers, authorized representatives and importers
- European database on medical devices
- Classification of devices and conformity assessment
- Clinical evaluation and clinical investigations
- Post-market surveillance, vigilance and market surveillance
Training does not include tasks and responsibilities of a notified body.
eLearning: which is given as self-paced web-based training. The content is available in Slovenian language. Training time depends on the basics that participant has in the field of good clinical practice, as the pace of content review depends on the individual. The training includes a test of knowledge. eLearning Centre User Manual.
Per client request we can arrange for a workshop with targeted training tailored to each manufacturer.
Knowledge test consisting of 20 questions. To obtain a certificate, 16 questions (80 %) should be answered correctly.
For more information, please contact us at: firstname.lastname@example.org.