About Introduction to MDR EU 2017/745 MEDICAL DEVICE REGULATION
Who can attend this course:
- Managers and Personnel responsible for the CE certification of medical devices
- Regulatory Affairs officer of certification evaluation for medical devices
- Quality Assurance personnel responsible for device and system compliance
- CE certification consultant of medical devices
This course enables you to understand the laws associated with the 2017/745 Medical Device Regulation and provides you with knowledge required for editing the technical documents for medical device manufacturers.
This course pack is designed to help you;
- Analyse of the differences between the regulations of MDD (Medical Devices Directory) and MDR (Medical Devices Regulation)
- Understand the structure of MDR
- Understand essential requirements of MDR.
- Gain knowledge about audit direction and process of Notified Body (NB)
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Course material is in English.
Presentation in English.
- Introduction of DNV GL
- MDR overview and status of transition
- MDD vs. MDR key changes
- Scope of MDR & key definitions
- General responsibility of manufacturers
- Economic operator / UDI
- Conformity assessment module, DOC and sampling criteria
- Classification rules
- Technical documentation
- GSPR (MDR) vs ERC (MDD)
- MDR clinical evaluation process
- MDR Post Market Surveillance and PMCF
- SSCP & PSUR
- MDR Medical Device Quality Management System
Are you looking for a customised course?:
Content of the course can be changed and modified depending on the need of the customer for private/inhouse courses.
Please contact us for more information.