Medical Device

Gap Analysis for Regulatory Compliance

EU MDR Gap Analysis

A GMP gap analysis evaluates whether your current facility meets EUMDR /USFDA requirements and is a great way to lower risk and bolster decision making for future revamp or optimization projects.

By knowing the state of your facility and current regulatory demands, your company can prioritize changes to get the most effective output.

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.

Performing an MDR Gap Analysis is essential when transitioning a device’s regulatory framework from the out-going Medical Device Directive MDD 93/42/EC to the new Medical Device Regulation (EU) 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.

An MDR Gap Analysis is your organization’s first step towards achieving maximum compliance with the EU MDR. At GAMP Group we understand your current regulatory resources might be exhausted with the European Commissions’ new guidelines that aim to improve fair market access, as well as to optimize clinical safety. The companies who are not able to fully implement these changes will be severely disadvantaged in the highly competitive and innovative Medical Device industry once the MDR takes effect in 2021.

EU MDR Gap Analysis: Procedures, Processes & CE Technical Documentation

GAMP Group Gap Analyses are conducted by our team of regulatory specialists to facilitate a smooth transition for your organization. With our guidance, your team will know precisely which areas your organization needs to revise in accordance with the new MDR. Our Gap Analysis will examine the current status of your company’s regulatory affairs, with a focus on your procedures, processes, and CE technical documentation. A thorough gap analysis is paramount, and it will offer strategic dividends in the future with your upcoming clinical activities.

Our involvement after we complete your gap analysis is designed to help best fit your particular needs. With our customizable consultative services, we can put together a plan that will mitigate all of the regulatory gaps found in our analysis. After reviewing the findings with your team, your leadership will be able to aptly assess which aspects of the MDR transition can be handled internally, and which elements require outsourcing. We often see our clients struggle to adjust to the expanded requirements without increasing their own resources, thus, possibly leading to regulatory deficiencies due to budget constraints. That is why it is vitally important that your Regulatory Team is proactive in mapping out how you will address the changes within the MDR, and a GAMP Group Gap Analysis is the logical first step.