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. RCA’s medical device consulting team shares their 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 postmarket 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.

 

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 that 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’s Medical Device Consulting Services

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

• SaMD Consulting
• Threat Modeling
• Proof of Concept
• Quality Assurance Services
• TIR 57 & TIR 97
• ISO 62304
• ISO 27001

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates^® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates^® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates^® medical device consulting company has expertise in both the approval process and post-approval support. 

• New Product Approval
• Post-Approval Support
• Outsourced Staffing
• EU MDR
• Combination Products

 

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates^® can help.

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates^® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

• Gap Assessments
• Internal Audits
• Employee Training
• Notified Body Response
• Data Integrity

 

Quality Assurance

Regulatory Compliance Associates^® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates^® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates^®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates^® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

• ISO13485 
• 21 CFR 210
• 21 CFR 211
• Outsourced Staffing
• MDSAP
• Facility Validation
• Equipment Validation
• Quality Metrics

 

Remediation Services

Regulatory Compliance Associates^® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates^® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

• Regulatory Action
• Regulatory Compliance
• Regulatory Enforcement
• Warning Letter
• 483 Observation
• Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates^®  a competitive differentiator in the remediation space.

• Quality System
• Technical File
• Design History File
• Data Integrity
• cGMP

 

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates^® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates^® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

• Manufacturing Optimization
• Product Lifecycle Management
• Mergers & Acquisitions (M&A)
• Due Diligence
• Device Vigilance
• Risk Management Plan
• Product Complaints
• Medical Information

 

About Regulatory Compliance Associates

Regulatory Compliance Associates^® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

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, Health Canada, MHRA and globally-regulated companies.

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

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

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