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Stage – ID5: Distribute the Product

This stage includes not only manufacture, quality control, packaging and distribution throughout the product's lifecycle, but also legal, financial, business development, training and other support activities.

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Task Overview

Once your clinical product is launched, it is important that you collect evidence to support its adoption. In some circumstances, such as if it is an implant, this may take several years to acquire. Proof of long-term efficacy and clinical outcomes require careful investigation, and the correct design of such studies is critical to their acceptance by healthcare professionals.

What you need to do:

  • Collate any published evidence in peer-reviewed journals as this will provide backing for your product. Include them in health technology assessment exercises when seeking approval to market the product overseas.
  • Where the product is a therapeutic device, you must report adverse incidents, based on formal post-market surveillance and vigilance systems, to the national Competent Authority (e.g. MHRA).


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