‘Gap analysis’ can be defined in several ways depending on the context. However, for our purposes, a gap analysis is the most proactive and low-cost method that allows MedTech companies to maintain the efficacy of their quality systems. It’s a formal comparative review of an internal procedure or process against a standard, good practice, regulation, etc. The GAP assessment also helps manufacturers decide on what resources to use and learn how their product portfolio will change given the more stringent MDR requirements.
This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745.
I. Purpose of a GAP analysis
Manufacturers can use a GAP analysis to identify areas of compliance with the MDR. They can also use it to find the gaps between the process and the MDR requirements they’re being compared against.
Simply said, it helps medical device manufacturers:
- Understand which requirements affect their company,
- Learn about their medical device classification according to the MDR
- Identify all gap areas of non-compliance,
- Learn how to meet the new EU MDR requirements,
- Customize their analysis based on the specific functions within their organization.
II. Execution time
MedTech companies shouldn’t leave the GAP analysis for last due to two reasons. First, the certification process starts with the GAP assessment. And second, they may need several months to correctly complete it.
However, using the help of product compliance experts can significantly shorten the execution time to less than a week. In general, medical device manufacturers should involve in the process experts from the regulatory field.
III. Areas to explore during a GAP analysis
A GAP analysis provides a toolbox for the decision-making process in MedTech companies. The “gaps” represent areas of non-compliance that highlight opportunities for improvement. Manufacturers can explore the following areas during a GAP assessment:
- Risk classification of the medical device
- Status of testing against current product safety standards (if applicable)
- Labelling requirements
- Clinical data and evaluation reports
- Risk management file
- Post-market surveillance system
- Agreements with suppliers, vendors and other economic operators
- Quality management system procedures
- Planned changes to products.
It’s good to note that not always the GAP analysis finds any gaps. Sometimes, the report outlines and explains how each MDR requirement is being met.
IV. Addressing gaps
If manufacturers find any gaps during the assessment, that doesn’t mean that there is a cause for concern. Once again, the GAP analysis is a tool that highlights opportunities for improvement. The very act of the GAP assessment indicates a documented effort towards continuous improvement, so long as all the gaps are addressed.
When addressing a gap, manufacturers should follow a traceable manner, one that shows the gap was detected, acknowledged and then fixed. Manufacturers should also state the way they fixed each gap.
If you need help with performing GAP analysis or any other aspect of the medical device CE certification, get in touch with Clever Compliance’s team at [email protected] We will review your case and then assign an MDR compliance expert to you.
Clever Compliance has helped countless startups, SMEs and large enterprises meet the MDR requirements and get their products on the EU market. Our digital approach to CE marking, experience and connections in the certification industry are some of the elements of our proven framework for success.