Gap Assessment
Analysis for EU MDR Compliance
An MDR gap assessment (also known as gap analysis) is the process of looking at a medical device’s technical file in a systematic way to determine if it meets all of the relevant MDR requirements. It is the first and most important step in understanding what needs to be done for a device to become MDR compliant.
This is applicable where a manufacturer already has a Medical Device Directive MDD 93/42/EC compliant device that needs to be transitioned. In order for devices on the market to maintain CE marking, MDR compliance is required. It’s also necessary when a device is new and not on the market yet. No matter how much, or how little, technical documentation is available for the device, a gap assessment can quickly identify what is missing.
Purpose of a Gap Assessment
A gap assessment is a proactive method that allows MedTech manufacturers to undertake a comparative review of what they have versus what they need. This is extremely useful. It not only highlights what is missing for the device to be compliant, but it helps manufacturers decide what resources are needed. It also provides a better understanding of how EU MDR compliant technical documentation should be structured.
The assessment highlights key findings so that manufacturers know which requirements affect their device. It identifies all areas of non-compliance. It can also compare requirements for MDD to MDR transitions, such as the MDD Essential Requirements which have been modified and updated to the MDR General Safety and Performance Requirements.
Execution of a Gap Assessment
Manufacturers should consider gap assessment as a priority. The certification process starts with the gap assessment and depending on what it finds, there might be a lot of work to complete.
It is always recommended to consider outsourcing the execution of this task. This has multiple benefits such as providing a systematic, impartial, and regulatory expert view to undertake the assessment. It also means that the task can be carried out separately to the internal teams’ day to day work which causes the least disruption.
Common Gaps revealed in Assessments
This greatly depends on the device and nature of the MedTech manufacturer. However, whether the device is already certified under MDD or is completely new and not yet on the market, there are some common areas that are revealed during gap assessment.
These areas include, but are not limited to:
- Classification and GSPR compliance updates for validation work
- Labelling requirements
- Instructions for Use (IFU) requirements
- Clinical data
- Clinical evaluation
- Risk Management
- Post Market Surveillance
- Economic Operator agreements
Addressing the Gaps
It is important to note that the gaps revealed in the assessment are identified to help, not just to cause additional work.
Notified Bodies are a lot more stringent on what they both expect and require under MDR. This also means that a transition plan can be created to address the gaps and show continuous improvement. This also shows NBs that there is a working strategy in place.
If you don’t have enough resources in-house, consider outsourcing additional elements of gap assessment findings to experts in the areas you need addressing.
Key Considerations
Priority
Manufacturers need to have all the device files available. However, if there are multiple devices to be assessed then it’s worth considering which are most important. This could be defined by device classification, the impact of not maintaining CE marking or how long it’s been since the device was last audited.
History
A good track record with past audits can work in your favour. Adversely, trying to withhold past issues can cause issues. Being transparent is the best tactic. When it comes to gap assessment, everything available should be assessed to provide the best results.
Changes
As above, being transparent is best here and providing everything for assessment will provide the most useful results. Any changes which have been made to the device (especially since previous submission) should be evident. Any other changes such as those in design, manufacturing or testing also need to be included.
Safety
All risk management, safety and performance and clinical investigation should be provided for the device. Safety is a key area throughout the MDR and ensuring your documentation contains either enough, or the correct information to be compliant is crucial.
Clin-r+ recommendations
Manufacturers should consider gap assessment as a priority and first call for their device(s). It can quickly identify areas for improvement and gaps in regulation requirements.
Our gap assessment has been designed to not only find gaps in EU MDR conformity, but also highlight opportunities for the device(s) and reduce the regulatory burden.
Once a gap assessment is complete, we recommend creating a timebound ‘transition’ project plan for closing the gaps. This plan should capture deliverables and remediate issues.
CLIN-r+ assists clients proactively by completing gap assessments, identifying non-conformances, and advising on how to implement strategic goals well in advance of deadlines. We ensure each gap has been closed, keep the plan on track and provide the support you need, where you need it.
Find out more information about how we can help with gap assessments in our case studies or get in touch!
