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Clinical Evaluation Requirements for Medical Device

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Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Clinical Evaluation Requirements for Medical Device

New MDR regulatory impacts the industry and ISO13485

Clinical Evaluations are required by the Medical Device Regulation to ensure the safety of devices marketed in the European Union. The requirements are clearly outlined. However, many manufacturers are challenged by 2017/745 and rejections by the reviewers are not uncommon. Industry expert, Chris Henza, shares her insights on compiling Clinical Evaluations, including tips from a recent submission.

 

CER & Clinical Evaluation

A clinical evaluation is the assessment and analysis of clinical evidence pertaining to a medical device in order to verify its clinical safety and performance. The clinical evidence is added to the clinical evaluation report (CER) for submission to regulatory bodies. Clinical evaluations are first performed prior to marketing of a medical device and then repeated periodically as new clinical safety and performance information about the device is obtained (e.g. an investigational device).

 

Medical Devices

Medical device companies, as the manufacturer, must demonstrate the device achieves its intended performance. Further, the risks and any adverse events are acceptable when weighed against the medical device manufacturing benefits of the device. Claims made about the device’s performance and safety are supported by suitable evidence or against ISO13485 certification.

 

Clinical Evaluation Example

With regard to a post-market surveillance clinical evaluation example, manufacturers are expected to implement and maintain surveillance programs which routinely monitor the clinical performance and safety of the device as part of their Quality Management System (QMS). The QMS should use data generated from safety reports for 21CFR 820 documentation. This includes adverse event reports, results from published literature, any further clinical investigations and formal post-market surveillance studies.

 

The stages of a clinical evaluation are outlined in Figure 1, below.

CER

Clinical Data

The literature review must be complete, covering pre- and post-market data and any clinical investigations in ISO 14971 certification or EU MDR approval. Common sources for data are:

  • Competitive products
  • Complaints
  • MAUDE database
  • Internal clinical testing
  • MedWatch
  • Published literature using common databases such as PUBMED and Science Direct, etc.

 

EU MDR

In collecting data for EU MDR submission and MDR approval, it’s helpful to print search pages including the search terms and exact logic used in the search. Boolean logic operators such as “AND” and “OR” show repeatability and helps the reviewers in analyzing the resulting clinical evaluation. For published literature, it is not uncommon for thousands of data sources to be identified (especially with medical instruments). In collecting data, it’s helpful to print search pages including the search terms and exact logic used in the search.

 

Data Evaluation

After data collection, the next step is assessing content and determining whether the data is considered for the clinical evaluation. A scoring table can be useful for determining whether or not to include data. For example, the data might be scored on factors such as device equivalency, application equivalency, similarity of operator and demographic equivalency.

 

Clinical Studies

Studies which pass the scoring table must be summarized on how they support the Essential Requirements (see Figure 1 above). A common mistake is simply copying the conclusion of the study instead of describing how it relates to the Essential Requirements. The clinical evaluation must be re-creatable by third parties based on the process and scoring system outlined in the report. If the notified body can’t re-create it, they have no recourse except to find deficiency in the medical manufacturing.

 

Regulatory Affairs

Make it easy for the reviewers to check off each step. Highlight what they are looking for relative to what you are covering. Refer to guidance and standards such as, The European Commission: Clinical Evaluation: a guide for manufacturers and notified bodies1 which features helpful appendices.

Common Errors:

  • Missing inclusion / exclusion criteria
  • Omitting applicable papers
  • Summarizing papers instead of evaluating them. Although a summary is required, the more important (and often omitted) portion is to explain how the data supports the Essential Requirements.
  • Forgetting summary tables
  • Forgetting a concluding argument. Explain how the document fulfills the requirements for the clinical evaluation.

 

Conclusion

Clinical evaluations include the CER, assessment and analysis of the medical device’s clinical data to verify its clinical safety and performance. The stages are well-defined, but can be intensive. A thorough clinical evaluation can involve thousands of data sources and significant time for proper assessment. Manufacturers should submit evaluations which are re-creatable and make it easy for reviewers to follow. Make it easy for the reviewers to check off each step. Highlight what they are looking for relative to what you are covering.

 

About RCA

Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

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