Learning Objectives
By the end of this training, you will be able to:
- Identify and understand the applicable regulatory requirements
- Identify the impacts of the regulation on economic operators
- Understanding the Steps in the CE Certification Process
- Quality Manager
- Regulatory Affairs Manager
- Any person involved in the implementation of the Medical Devices Regulation
- A general understanding of the medical device industry is a plus.
- Prior experience with EU Regulation 2017/745 is not required
- Format: virtual or in-person class
- In-house training available: please contact us
- Registration deadlines: Registration closes 24 hours before the session. Maximum of 10 people. Minimum of 3 people.
- Accessibility: Accessible to everyone. If you require special accommodations due to a disability, please contact us.
Training Program
- History of European Regulation
- Objectives and Scope of the MDR
- Key Definitions
- The manufacturer
- The distributor
- The importer
- The Agent
- The PCVRR
- Registration of Economic Operators
- Medical Device Records
- Notified Bodies and Certificates
- Vigilance and PMS
- Clinical Investigation
- Market Surveillance
- Principles of Medical Device Classification
- Classification Criteria and Rules
- Product covered by Annex XV
- Contents of the Technical Documentation
- Present Your Plan
- Coding (EMDN, Basic UDI-DI, MDR Codes)
- Claimed Use
- Specifications
- Response to the EGSP
- Risk Management
- Design and Manufacturing Requirements
- Product Verification and Validation
- Clinical Evaluation
- The Declaration of Conformity
- Post-Marketing Surveillance Requirements
- Post-Marketing Surveillance System
- Incident Reporting and Corrective Action Management
- Selection of the Notified Body
- Conformity Assessment Procedure
- Submission of the Technical Documentation and Expectations of Notified Bodies
Monitoring and Evaluation Procedures
- Attendance Sheet
- Mini quiz / practice exercise at the end of each learning objective
- Final Review Quiz at the End of the Training Course
- Satisfaction Survey
- Training Certificate
Technical and Educational Resources
- Technical Requirements: Microphone, webcam, and internet connection required; a Microsoft Teams link will be sent 24 hours before the workshop.
- Methods Used: Training materials provided to trainees by the instructor. Practical exercises, discussions, and sharing of experiences.
Speaker
Medical Device Trainer: Significant professional experience in the field of medical devices >5 years.
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