Device – Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process

Our one-day course has been designed to provide manufacturers with the knowledge and skills to interpret the requirements of the drug consultation process for devices containing ancillary medicinal substances. 

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 the realistic timescales involved for the consultation process and an awareness of common mistakes to avoid, ensuring delays are minimized. 

This course focuses on determination of the applicable European legislation for borderline products, and provides insight into further information and guidance related to the distinction between medical devices and medicinal products. This course also examines devices incorporating derivatives of human blood or plasma. 

Who should attend?

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

Learning objectives

  • Differentiate between a medical device and medicinal product in terms of classification  
  • Introduce and explain the key stages involved in the consultation process  
  • Guide a product development team through the planning process identifying realistic timescales
  • Explain the consultation documentation requirements
  • Identify common pitfalls and potential competent authority questions in relation to the drug consultation  
  • Appreciate notified body expectations in relation to documentation that requires submission
  • Evaluate changes made after a product goes through the CE marking process

Course Benefits

  • Increase your speed to market
  • Decrease your risk of liability
  • Manage your risks better
  • Provide better assurance to stakeholders

Next Steps

  • Implementing ISO 13485 - Our Implementing ISO 13485 two-day course is designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2003 certification
  • Introduction to: CE Marking - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker
  • Medical Devices Risk Management: ISO 14971 - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.