EU MDR Gap Assessment Services

Start your journey to EU MDR compliance with a clear, structured Gap Assessment.
Identify what’s missing, and help you fix it before MDR audits or notified body reviews.

Services We Offer

MDR Compliance Gap Audit Services

Procedures, Processes, and CE Technical Documentation 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.

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.

Our EU MDR Gap Analysis Methodology

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

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

🧾EU MDR Technical Documentation and QMS Mapping

Most teams think their documents are in place—until a gap analysis shows what’s missing. That’s where we come in. Getting MDR-compliant isn’t just about having documents. It’s about how well they reflect what you actually do.

Let’s break that down.

🔍 What We Look At

Are your technical files consistent with real-life processes?
Does your QMS talk to your documentation — or are they telling two different stories?
Are documents like CER, SSCP, or PMS plans aligned with the latest MDR expectations?

⚠️ Common Issues We Spot