Purpose of a clinical evaluation under the EU MDR

Article 61(1) of the EU MDR indicates that manufacturers ‘shall plan, conduct and document a clinical evaluation’ to enable:

Confirmation of conformity with relevant general safety and performance requirements … under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk ratio … shall be based on clinical data providing sufficient clinical evidence

This fits well with the definition of ‘clinical data’ in Article 2(48), which implies that the purpose of the clinical evaluation is ‘to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer’.

However, this is not the complete picture. Synthesizing the requirements from Article 61 and Annex XIV of the EU MDR with the additional clarifications provided by guidance such as MDCG 2020-5 and 2020-6, the clinical evaluation must also:

• Clearly identify the intended purpose and associated clinical benefits of the device(s) as well as the conditions of use and specific contraindications, in a way that can be justifiably supported by the available clinical evidence
• Establish outcomes achievable with other state of the art (SOTA) therapies for the same patient populations and treatment indications, to determine benchmarks for safety, performance and benefit-risk of the subject device
• Justify the sources of data used, including use of equivalence and non-clinical evidence, if applicable
• Draw conclusions not only regarding safety, performance and benefit-risk, but justify the completeness of the evidence to support:
  • all indications (including those implied by broad intended purpose statements)
  • all potential patient populations, with particular reference to high risk or vulnerable populations
  • all device variants and combinations
  • usage with accessories and other devices, where applicable
  • device lifetime in use
  • risk identification/confirmation of risks identified through the manufacturer’s risk management processes
  • acceptability of residual risks

Stated more succinctly, the purpose of the clinical evaluation is to demonstrate, with objective and scientifically valid evidence, that the device does what it is supposed to do, achieves its intended clinical benefits (whether direct or indirect) and that the benefit-risk conclusion is acceptable in comparison to other available therapeutic or diagnostic options.

This blog post is an excerpt from our latest white paper: Clinical evaluation under EU MDR. Please download the full white paper to find out more.