Regulations for medical devices in the European Union are going through the most comprehensive revision since they were created in the 1990s. These revisions are driven in part by technological advancement. They are also aimed at ensuring safety and effectiveness of medical devices in response to several high-profile product scandals in recent years. Key changes have resulted in clinical evidence requirements, pre-market review of the technical file by notified body, post-market surveillance and vigilance, transparency and traceability through Unique device identification (UDI) and strengthening of the oversight of the medical devices by the notified body.

As the EU transitions to this new standard of regulations, medical device companies need to prepare to be in alignment with new standards. Not only do new device designs need to be in compliance with new standards, but all existing products and technologies must be recertified.

Students in European Medical Device Regulation will learn the details of the new regulations, and how to serve their organizations’ needs for highly qualified regulatory affairs, clinical affairs, and quality assurance professionals.

Learning Outcomes

At the conclusion of the course, you should be able to

• Learn medical device regulations definitions and requirements, including how to implement medical device regulations program for existing and new products, and the impact of quality management systems (QMS) due to medical device regulations (MDR).
• Understand scope of changes from current medical device directive (MDD) to MDR.
• Know MDR classification and conformity assessment.
• Implement clinical evaluation plan and report.
• Identify economic operations in your supply chain.
• Recognize unique device identification (UDI), the European database on medical devices (EUDAMED), and information technology requirements.
• Deploy post-market surveillance, report serious incidents, and field corrective actions.
• Employ smart strategies to reduce the overall cost of implementing the medical device regulations.
• Avoid ISO audit and EU competent authority inspection observations by following a sound regulatory path.

Topics Include

• Supply Chain & Economic Operators
• Clinical Data & Evaluation
• UDI, EUDAMED, IT requirements
• MDR Implementation Program

Additional Information

Prerequisite Courses:
MEDD.x407 - Quality Systems for Medical Devices FDA QSR, ISO 13485 (recommended), and REGL.x404 - Regulation of Medical Devices and Diagnostics (recommended)