With ever-increasing challenges facing medical device companies in the form of more stringent regulations, higher patient expectations and commercial pressures in fast moving markets, the regulatory profession continues to grow in importance and prominence. Regulatory professionals have become key contributors to a company’s ability to devise successful business strategies and execute these strategies effectively. Therefore, they need to build up a robust regulatory expertise by continuously maintaining and expanding their knowledge and understanding of regulations and emerging technologies.
This course provides a basic understanding of medical device regulation in the European Union (EU). You will review the history of medical device regulation for Europe and follow the regulatory requirements through the lifecycle of the product. You will gain a strong foundation of the key elements of the EU directive requirements, including the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, Medical Devices Directive (MDD) 93/42/EEC and In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC. You will examine how devices are classified and how this classification affects the labeling, registration, marketing and postmarketing requirements.
Learning Objectives
Upon completion of this course, participants will be able to:
- Outline how medical devices are classified using a European framework
- Identify the unique elements of the European regulatory directives
- Discuss the unique features of preclinical and clinical testing in Europe
- Describe the conformity assessment pathways for obtaining CE marking
- Cite the key requirements for postmarketing surveillance
Target Audience
This program is designed for new regulatory professionals and others in related departments interested in understanding the basics of the regulation of medical devices in the EU.