A guide to MDR Gap Analysis

An MDR Gap Analysis enables optimal allocation of resources & targeted evidence generation

What is an MDR Gap Analysis?

An MDR Gap Analysis is the process of systematically examining a medical device’s clinical evidence portfolio to determine whether it demonstrates conformity with all relevant MDR requirements. It is a crucial first step in developing and maintaining an MDR compliance strategy.

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Performing an MDR Gap Analysis is essential when transitioning a device’s regulatory framework from the out-going Medical Device Directive (MDD) to the new Medical Device Regulation (MDR) 2017/745. Undertaking an MDR Gap Analysis will enable the identification of any gaps in the clinical evidence portfolio, allowing measures to be taken to address these gaps before engaging a regulatory body.

Performing an MDR Gap Analysis correctly requires:

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

What has the MDR changed about Gap Analysis?

Where MDR Gap Analysis fits into the medical device regulation environment
Fig 1: Where MDR Gap Analysis fits into the medical device regulation environment

The MDR has introduced a number of changes that have a bearing on the conduct of Gap Analysis.

After the MDR is fully implemented in May 2021, every medical device must demonstrate conformity with all MDR Annex I General Safety and Performance Requirements (GSPRs) that are relevant to that device. The MDR GSPRs replace the Essential Requirements in the MDD and are more extensive and detailed, meaning that evidence portfolios that were sufficient for the MDD may no longer be comprehensive enough for the MDR.

Furthermore, the MDR requires a more granular level of evidence that relates to specific indications and target patient populations that may be exposed to the device. This means that clinical evidence gaps may reveal themselves when individual indications and patient populations are under consideration.

The MDR also introduces additional requirements for Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). A detailed understanding of these requirements enables our experts to identify opportunities to address some types of evidence gap through advising on the design objectives for PMCF studies.

Performing Gap Analysis for the MDR and formulating gap-mitigation strategies is a specialised task that greatly benefits from the involvement of an expertly-trained medical professional.

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