General Knowledge of IVDR
1 490 €
Get familiar with the essentials of the IVDR – quickly, clearly, and online!
During the training, you will gain comprehensive knowledge about the most important provisions of the IVDR, the legal background of the free movement of goods, EU institutions, conformity assessment procedures, and the obligations of different economic operators.
Information
The training material is available interactively through an e-learning platform anytime and anywhere, allowing you to learn entirely at your own pace.
Your acquired knowledge will be assessed through online quizzes, and upon successful completion, you will receive a certificate confirming completion of the training.
✓ Author: Attila Juhász (Professional Director, SAASCO Consulting and Engineering Ltd.)
✓ Access to the course material for 6 months from the date of purchase
✓ 220-page training material explaining EU fundamentals and IVDR requirements in an easy-to-understand way✓ Online tests to reinforce your knowledge
✓ Certificate documenting completed course modules and achieved results
Do you have questions about the course content? Simply send us an email at info@noboversum.hu and we will forward your question to the expert for a professional response.
Topics
- Legal foundations of the free movement of goods
- EU legal acts
- Institutions of the European Union
- Definitions related to CE marking
- What does CE marking mean?
- When is CE marking mandatory for a product?
- The CE marking process
- Economic operators – definitions
- General obligations of manufacturers
- Obligations of authorised representatives
- General obligations of importers
- General obligations of distributors
- Special cases
- Why is market surveillance necessary?
- Market surveillance activities
- Monitoring serious incidents and field safety corrective actions
- Authorization of performance studies
- Verification of data entered during the registration of economic operators
- Designation and monitoring of notified bodies
- Requirements applicable to notified bodies
- Designation and notification procedure
- Monitoring of notified bodies
- Conformity assessment roles and competence codes
- Internal processes of notified bodies
- Purpose, structure, and application of the IVDR
- Definitions
- Scope, placing on the market, claims
- Device identification and traceability, EUDAMED registration
- Classification and conformity assessment
- Performance evaluation and performance studies, including related documentation
- Post-market surveillance and vigilance
- MDCG, expert laboratories, and expert panels
- Transitional periods and deadlines
- Structure and content of technical documentation
- Availability of MDCG guidance documents
- Legal status of MDCG guidance documents
- Most important MDCG guidance documents
- Application of harmonised standards
- Application of common specifications
