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All of your hard work has been leading up to this. So far in the clinical evaluation process, you’ve made a plan, gathered clinical data, and appraised its relevance and quality. Now, it’s time to analyze that data to determine if your device is compliant with safety and performance requirements in the European Union.
This can be a tricky stage in the clinical evaluation process, so for the third part of our four-part series on clinical evaluation of medical devices, we’re going to dive into what data analysis really entails and what you’re hoping to achieve with it.
WHAT TO EXPECT IN THIS 4-PART SERIES
|Part 3: Performing Data Analysis for Your Medical Device’s Clinical Evaluation (this article)
Ideally, your data analysis will demonstrate that the clinical data you’ve gathered shows your device to be safe and effective for end users and patients.
Under the previous Medical Device Directive (MDD), this meant demonstrating compliance with the MDD’s Essential Requirements covering safety, performance, and risk-benefit profile.
However, the MDD has been replaced by the European Union Medical Device Regulation (EU MDR), which has a new set of requirements known as the General Safety and Performance Requirements (GSPRs).
There are more GSPRs than there were Essential Requirements, but their scope is similar—they are still criteria for safety, performance, and benefit-risk profile that your device must meet to receive its CE marking.
Keep in mind that there is a strong connection between the analysis of your clinical data and risk management. Appendix A7 of MEDDEV 2.7.1 Rev. 4 repeatedly references the use of risk management documents as a means of determining knowledge gaps that need to be covered by clinical data and identifying whether all known risks to patients and users have been minimized.
This should be a good reminder that risk management is more than a checkbox activity—it’s integral to getting a safe and effective device to the patients who need it most.
“Analysis” is a broad term, which is why it’s important to read all the guidance surrounding clinical evaluation carefully and hew to its recommendations. For instance, MEDDEV 2.7.1 Rev. 4 offers a four-point plan for evaluators during the analysis stage of clinical evaluation:
During the appraisal stage, you weighted your data sets to ensure that the most relevant data from the highest-quality studies would be given the most consideration in your analysis.
MEDDEV 2.7.1 Rev. 4 states that you may use quantitative or qualitative methods to analyze this data. However, it also states that available clinical data should generally be quantitatively assessed in relation to state of the art (STOT), meaning the current best practices on the market. You may use qualitative methods in some cases, but if you do, you must also justify their use.
Your analysis will also need to include all the data sets you identified and appraised in earlier stages, looking for consistency around device performance and any risks you’ve identified. If there’s conflicting information, the weighting process you performed during appraisal will help you decide how to evaluate the conflicting data.
Remember, the goal of your analysis is to determine compliance with the General Safety and Performance Requirements in Annex I of EU MDR.
According to MEDDEV 2.7.1 Rev. 4, your evaluation of whether your device is compliant with the GSPR should include:
An assessment of the adequacy of pre-clinical testing—such as bench tests or animal tests—to verify safety, risks to patients, and benefits to patients.
Confirmation that the device performs as you claim it does.
Confirmation of the device’s usability. In other words, the device’s design reduces the risk of error as much as possible and that the design is appropriate for the intended user.
Assurance that the information supplied by the manufacturer is adequate and that risk mitigation measures are addressed in the instructions for use (IFU).
You’ll also need to identify any gaps in the evidence you’ve collected, including aspects like your understanding of the interaction between the device and the body and the comprehensiveness of the available data.
Finally, you’ll need to assess the consistency and alignment between the clinical evaluation, the information supplied by the manufacturer, and your risk management documentation for the device.
Once you’ve done so, you’ll then assess whether there is consistency between those documents and the STOT. Discrepancies between the documents themselves or between the documents and the STOT should be identified during the analysis.
Did you know Greenlight Guru has a dedicated Risk Management workflow to help you easily execute these steps? You’ll be able to conduct risk analysis evaluation in a traceable system, capturing and recording relevant data throughout the design and development process.
The purpose-built solution makes it easy to keep your risk management file up-to-date and living throughout the entire lifecycle by electronically reviewing, signing, and approving documentation with a single source of truth.
It’s possible that the analysis of your clinical data will turn up some gaps. Perhaps the data you have related to the safety or performance of the device isn’t strong enough to determine your device’s compliance with some of the GSPRs.
In such a case, you would need to generate the missing data required to confidently draw conclusions about your device’s conformity with the GSPRs. This may require a clinical investigation.
Your postmarket clinical follow-up (PMCF) is a part of your mandated postmarket surveillance activities under EU MDR. The PMCF is a continuous process of updating your medical device’s clinical evaluation once you’ve obtained CE marking. The goal is to ensure the safety and performance of the device over its lifetime, and it should identify any emerging risks through the collection of clinical data.
The final step in the data analysis stage is to describe any residual risks, uncertainties, or unanswered questions that your PCMF will need to collect data on once the device reaches market.
NOTE: You may notice that MEDDEV 2.7.1 Rev. 4 references “Essential Requirements” rather than “General Safety and Performance Requirements”. This is because MEDDEV 2.7.1 Rev. 4 is actually based on the older MDD.
However, the European Commission has issued a guidance document, MDCG 2020-6, on Sufficient Clinical Evidence for Legacy Devices. In Appendix I, the document states that the sections of MEDDEV 2.7.1 Rev. 4 related to the analysis of data are still relevant under MDR.
Your clinical evaluation may be complete, but your findings still need to be documented and delivered to your Notified Body. In the final article of our four-part series, we’ll cover how to write your clinical evaluation report.
Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your post-market activities with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →
Niki Price is a Medical Device Guru who has spent her entire career working with different types of medical devices. She began her journey in production, which is where she discovered how important and fulfilling this line of work was to her! Spending time in both Quality and R&D, she enjoys the product development...