The European Union Regulatory System for Medical Devices
This course will provide you with a clear and comprehensive understanding of the European regulatory model along with its key principles in ensuring the safety of medical devices and bringing them to market efficiently.
As well as exploring EU directives, key players, definitions and classifications, you will also acquire an understanding of conformity assessment procedures, quality system requirements and evaluations using ISO 14155, including directives 93/42 and 90/385 (and subsequent updates) as well as related product-specific directives, combination products requirements, interactions with the directive for pharmaceutical products, tissue engineering products and others, as per demarcation guidance.
Upon completion of this course, trainees will be able to correctly and successfully comprehend and define the working fundamentals of the European Regulatory System for Medical Devices including:
- Basics of the 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 classification of medical devices
- Conformity assessment procedures or routes
- Quality system requirements
- Essential Requirements found in Annex 1 and the use of harmonized standards
- Clinical data and evaluations using ISO 14155
- TF and DD requirements
- Medical device vigilance
- Demarcation with other directives
- Role of Notified Bodies (MEDDEV 2.7.1 Rev 3, NBOG requirements).
Any medical device professional working on an EU medical device project.