EU MDR Gap Assessment

Your organization's first step to achieving complete compliance with the EU MDR is to conduct an EU MDR Gap Analysis. Artixio is aware that the new regulations from the European Commission, which are intended to enhance clinical safety and fair market access, may have depleted your current regulatory resources. Once the MDR goes into force in 2021, the businesses that are unable to completely implement these changes will be severely handicapped in the highly inventive and competitive medical device market.

 

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Procedures, Processes, and CE Technical Documentation EU MDR Gap Analysis

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Artixio’s team of regulatory experts performs gap analyses to help your firm move smoothly. Your team will be able to identify precisely which areas need to be changed at your company to comply with the new MDR with our assistance. With a focus on your policies, practises, and CE technical documentation, our gap analysis will look at the current state of your business' regulatory affairs. It is crucial to conduct a thorough gap analysis because it will pay off strategically with your planned clinical efforts.

 

Our engagement is intended to better meet your specific needs after we finish your gap analysis. With the help of our individualised consulting services, we can create a strategy to close all of the regulatory gaps identified by our investigation. Your leadership will be able to accurately determine which aspects of the MDR transition can be handled internally and which components require outsourcing after analysing the findings with your team. Our clients frequently struggle to meet the new criteria without growing their own resources, which could result in regulatory shortcomings because of financial limitations. Because of this, it is crucial that your regulatory team takes the initiative to plan how you will respond to the changes in the MDR.

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Our analysis of your compliance with EU MDR 2017/745 identifies the following gaps:

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• Classification of the device(s) in use now, assessing if the classification has changed

• Assessment of Technical Documentation, its completeness and design history files 

• Clinical Evaluation Reports and Literature Reviews 

• Risk Management Documentation and Procedures 

• Assessment of testing to current standards 

• Post market surveillance standards and processes

• Agreements related to Economic operators 

• Supply chain management procedures 

• Device lifecycle management 

• Label review, updates and label lifecycle management procedures 

• UDI compliance