This one day course has been designed to provide manufacturers with the knowledge and skills to interpret the regulatory requirements relating to materials of animal origin, including those for which a TSE risk is expected.

Attendance on this course will provide guidance on how to reduce risks and uncertainty in the EU regulatory process. Participants will gain an appreciation of typical hazards associated with animal tissues & derivatives, the justifications needed to use these materials and awareness of common mistakes to avoid in sourcing, collection and handling ensuring delays are minimized.

This course focuses on determination of the applicable European legislation and guidance including 93/42/EEC, 90/385/EEC, 2003/32/EC, EN ISO 22442 and MedDev 2.11.1.

Learning Objectives

On completion of the training, participants will be able to:

• Determine the current legislative approval process
• Explain the key stages involved in the consultation process under 2003/32/EC
• Identify the requirements for demonstrating control over suppliers of materials of animal origin
• Appreciate Notified Body expectations in relation to submission documentation
• Identify common pitfalls and potential Notified Body and / or Competent Authority questions
• Identify the requirements for gathering post-production information

Who Should Attend

• Professionals working in Regulatory Affairs, Research and Development
• Consultants
• Project managers and any staff involved in the product to market process

Prerequisite

Participants should have experience and/or a basic knowledge of medical device product development. Together with an awareness of the MDD or AIMD and Directive 2003/32/EC.

This course can be delivered as in-company training, customized for specific organizations and their circumstances.