General Knowledge of MDR
1 490 €
Understand the fundamentals of MDR — quickly, clearly and fully online!
During the course, you will gain comprehensive knowledge of the key MDR requirements, the legal framework governing the free movement of goods, EU institutions, conformity assessment procedures, and the obligations of the different economic operators.
Information
The course material is available anytime and from anywhere through an interactive e-learning platform, allowing you to learn entirely at your own pace.
Your knowledge will be assessed through online quizzes, and upon successful completion, you will receive a certificate confirming the 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 course material explaining EU regulatory fundamentals and MDR requirements in a clear and practical 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
- Definitions
- Scope, placing on the market, claims
- 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 clinical investigations
- 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
- Relationship between economic operators, notified bodies, and competent authorities
- Device identification and traceability, EUDAMED registration
- Classification and conformity assessment
- Involvement of notified bodies in conformity assessment procedures
- Content and validity of certificates issued by notified bodies
- General requirements and documentation for clinical evaluation and clinical investigations
- Post-market surveillance and vigilance
- MDCG, expert laboratories, and expert panels
- Transitional period and deadlines
- Structure and content of technical documentation under the MDR
- Precise technical description of the device, including variants and accessories
- Information supplied by the manufacturer
- Information related to design and manufacturing
- General Safety and Performance Requirements (GSPR)
- Benefit-risk analysis and risk management
- Product verification and validation
- Availability of MDCG guidance documents
- Legal status of MDCG guidance documents
- Most important MDCG guidance documents
- Application of harmonised standards
- Application of common specifications
