Gap Analysis

A Gap Analysis is a crucial first step in developing and maintaining an MDR compliance strategy.

This involves a structured assessment of a medical device’s clinical evidence portfolio and is done to determine whether it demonstrates conformity with all relevant MDR Annex I General Safety and Performance Requirements.

All medical device Clinical Evaluations should begin with a Gap Analysis. Undertaking a Gap Analysis first will enable the identification of any gaps in the clinical evidence portfolio, allowing measures to be taken to address these gaps before spending time and money on a Clinical Evaluation.

It is critical to perform a Gap Analysis correctly otherwise false assumptions will carry forward into the Clinical Evaluation. Performing a Gap Analysis effectively requires:

  • a thorough understanding of the Annex I General Safety and Performance Requirements,
  • an ability to search, assimilate and critically appraise clinical evidence,
  • a capability to make recommendations for addressing any gaps identified.

Our team of specialist medics are experts in this area and will use their clinical expertise to perform an independent, market-leading Gap Analysis on your medical devices. This is a highly recommended step in transitioning to the MDR.

Our services include:

  1. Analyse the Annex I General Safety and Performance Requirements (SPRs) to identify those that are relevant to each product.
  2. Perform a detailed analysis and critique of your existing clinical evidence portfolio to identify any gaps in demonstrating conformity.
  3. Undertake a detailed systematic literature review to search for and appraise clinical evidence that may address any gaps in the existing portfolio.
  4. Make recommendations for most effectively addressing any remaining gaps through documenting a clinical development plan.
  5. Advise on the impact of the Gap Analysis to risk management processes.

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