Fundamental Training on CE certification in Medical Devices

Learning Objectives:

On completion of training, participants will be able to:

• European CE Marking approach and its legal and operational requirements.
• Understanding of EU Medical Device Regulation.
• Implement the EU risk classification criteria for medical devices
• Identify the conformity assessment routes and quality assurance requirements for the various risk classes
• Describe the role of the essential requirements as the basis for CE Marking, including the use of standards
• Explain the importance and role of clinical data
• List labeling requirements
• Identify the regulatory significance of risk management and process validation
• Identify the necessary steps required for post market surveillance for different risk classes
• Interpret the criteria for reporting adverse incidents under the vigilance system
• Define the manufacturer’s regulatory responsibilities, including reporting of changes to products and QMS system to the Notified Body
• Identify technical documentation requirements
• Identify the relevance of recent changes to the medical device directives
• Conduct internal and external audits for compliance with the directives

Who Should Attend:

• Regulatory, quality, design, development, manufacturing, marketing managers and personnel handling medical devices
• Organizations preparing ‘own branding’ or ‘private labeling’ of devices
• Potential internal auditors and others who need an in-depth knowledge of the requirements of the medical devices directives.

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