Module 15 2022

5/19/2022

Case Study: Implementing a compliant clinical evaluation process

• A manufacturer of a class III implantable device (CE-mark 5 years under 93/42/EEC) containing an ancillary substance “coated or grafted or impregnated” under a special treatment to add an anti-microbial claim needs to create/ document/ formalize a process and associated procedure(s) related to clinical evaluation within the company through device life-cycle. • This manufacturer wishes to transition the device to the MDR, but is also planning on developing a new version capitalizing on this platform. None of their devices have actual clinical data, and so far nothing was planned to generate clinical data on their devices (the manufacturer intends to continue with the literature route of equivalence). • Using EU MDR 2017/745, MEDDEV 2.7/1 Rev 4, MDCG guidance, and the knowledge you gathered from these lectures, as well as any other relevant Standard or Guidance relevant for this topic, may you please : • Draft a road map (action plan) of what are the necessary actions (general overview) to be considered (strategic plan) • For each key effort, draft the necessary tasks/chapters of the documentation required • Identify any collateral activities that may be impacted as well as the communication path to move these forward

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© NAMSA 2021

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