The European Union Regulatory System for Medical Devices
This course provides a clear and comprehensive understanding of the EU regulatory model. It focuses on key principles essential to both ensuring the safety of medical devices and bringing them to market efficiently.
This course covers the following topics:
- EU directives
- Key players, definitions, and classifications within the EU Regulatory System
- Conformity assessment procedures
- Quality system requirements and evaluations using ISO 14155 (including directives 93/42, 90/385, and subsequent updates)
- Related product-specific directives
- Combination product requirements
- Interactions with directives for pharmaceutical products
- Tissue engineering products
- Additional products taken from the demarcation guide
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Upon successfully completing this course, trainees will be able to:
- Comprehend and define the working fundamentals of the European Regulatory System for Medical Devices, which includes:
- Basics of EU medical device directives, including roles and responsibilities of key players such as notified bodies and competent authorities
- Structure of the MDD and other directives
- Definitions and classifications of medical devices
- Conformity assessment procedures
- Quality system requirements
- Essential requirements found in Annex 1 and the use of harmonized standards
- Clinical data and evaluations using ISO 14155
- Technical File and Design Dossier requirements
- Medical device vigilance
- Demarcation with other directives
- Role of notified bodies (MEDDEV 2.7.1 Rev 3, NBOG requirements)
Regulatory Affairs Associate, Regulatory Affairs Manager, Quality Assurance Associate, Quality Assurance Manager, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Notified Body Auditor, Regulator, Electrical Safety Engineer, Internal Auditor, Lead Auditor, Pre-Clinical Study Manager, Clinical Affairs Director, Clinical Project Manager, Export Manager, and R&D Engineer are welcome to participate in this course.
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.