Difference Between CE mark and FDA Approval: Detailed Guide

In this blog, we have highlighted the key differences between CE mark and FDA approval. Additionally, we have discussed which is easier to secure and the required timelines for approval. This blog will be especially helpful for those entering new international markets.

Pre-audit requirements for CE mark and FDA approval

Two major pathways dominate the medical device regulatory space. CE mark certification for the European market and FDA 510(k) clearance for the United States. We have highlighted the major requirements for CE mark and FDA approval processes.

CE mark certification:

1. Identification of directives: Identify applicable EU directives for your device.
2. Technical document preparation: Prepare thorough technical documentation to support your CE mark application.
3. Comply with medical device labelling guidelines: Ensure proper CE mark guideline-compliant labelling of your medical device.
4. Risk assessment: Conduct a comprehensive risk assessment for your device.
5. Select a notified body: Select a reputable notified body.
6. Quality management system: Implement a thorough and robust ISO 13485-compliant quality management system (QMS).
7. Post-market surveillance requirement: Develop a thorough monitoring plan for post-market performance of the medical device after regulatory clearance.

FDA 510(k) clearance:

1. Device classification: Determine your device’s FDA classification. This is a vital step as it will determine your device’s FDA regulatory requirement.
2. Predicate device: Identify a suitable “predicate device” for your medical device for US FDA 510(k) clearance.
3. Thorough document preparation: Compile a comprehensive US FDA 510(k) documentation for your application.
4. Quality system regulation: Establish an FDA-compliant quality system regulation (QSR).
5. 510(k) application submission: Submit your US FDA 510(k) application to the FDA.
6. Provide timely response to FDA queries: FDA may raise queries regarding your application and request for additional information. Promptly respond to FDA requests and queries.
7. Post-market surveillance: Post-market surveillance is an important FDA requirement. Implement thorough post-market surveillance procedures to monitor your medical device in the market.

CE mark vs FDA approval: Which is more complex and rigorous?

CE mark certification and FDA 510(k) process both are complex and rigorous in their own ways. Moreover, the complexity of the regulatory pathway will vary depending on the specific product being certified. 

• CE mark certification: For CE mark certification, the type of product and its specific requirements will determine the level of complexity of the regulatory process. In case of CE mark certification, manufacturer is responsible for ensuring compliance with all relevant EU-wide requirements for the medical device. Additionally, the manufacturer has to determine whether they can assess their product by themselves or whether a notified body will be required. Furthermore, a notified body will demand fees for their service. Moreover, the manufacturer will have to prepare a technical dossier demonstrating compliance.
• FDA 510(k) approval: The FDA 510(k) approval process is comparatively complex. It is used to demonstrate the device is as safe and effective as the predicate device. The manufacturer has to prove the new device is substantial equivalent to another device already on the market. Furthermore, the 510(k) application can be of approximately 35 pages. Moreover, depending on the complexity of the medical device, it can be of 100 pages or more.

Thus, US FDA 510(k) approval is slightly more demanding and complex than the CE mark certification process.

Time required for CE mark and FDA approval

Varying in complexity and requirements, CE mark and US FDA 510(k) clearance processes have different timelines for approval.

• CE mark: CE mark certification process takes approximately four to six weeks time for approval. However, the approval process can take longer, if the product needs modification or the technical documentation is not fully complete.  
• US FDA 510(k) clearance: US FDA 510(k) clearance process can take approximately 177 days, i.e., 6 months. However, the clearance time may be longer, if there are outstanding review issues regarding the device.

Notably, these are average durations for CE mark and FDA approval. The actual timeline will vary depending on the complexity of the medical device, the documentation required, and various other factors.  

Renewal of license: Validity of CE mark and US FDA 510(k) approval

• CE mark certification: The CE marking certification for medical devices is usually valid for a period of three years. After this period, the certification has to be renewed. Notably, it is recommended to start the registration renewal process at least 6 months prior to the expiry of the certification. 
• FDA 510(k) clearance: On the other hand, the FDA 510(k) clearance does not have a specific expiration date or period of validity. It remains valid as long as the new medical device remains substantially equivalent to the predicate device. However, changes warrant a new submission. Moreover, if the FDA deems the device is not substantially equivalent, a new 510(k) with new data may be required. 

Which is easy to secure for a medical device? CE mark certification or US FDA 510(k) approval

The specific medical device, its type, and intended use along with other factors affect how difficult it is to obtain an approval for the medical device. However, usually securing the CE mark certification is considered simpler and easier than getting US FDA 510(k) approval. 

• CE mark certification: The CE mark certification process is usually quicker, less expensive, and more dependable. The manufacturer is expected to ensure all pertinent EU-wide requirements for the medical device have been complied. If the device complies with strict safety, health, and environmental protection benchmarks, it may be granted the CE mark certification. 
• US FDA 510(k) approval: In contrast, the FDA 510(k) approval process is a lot more complex. It requires proving the new device is substantially equivalent to an already marketed device (predicate device). The applicant has to demonstrate the new device is as safe and effective as the predicate device. The FDA 510(k) approval process is cumbersome and labour intensive as well as time consuming.

How can Pharmadocx Consultants help?

Navigating the complexities of securing the CE mark and FDA approval for your medical device is a challenging task. It can be a huge ordeal for new entrants in the medical device sector. Fret not! With the help of the Pharmadocx Consultants team, this is going to be a cake walk. We are well versed with the regulatory guidelines and requirements of CE mark and FDA approval. Additionally, we will help you easily identify the guidelines applicable to your device. Our team of experts has extensive knowledge in this domain and will guide you in every step of your journey. We provide the following services to our clients:

1. Identification of applicable EU directives for your device
2. Identification of FDA product code and applicable regulations
3. Verification of applicable standards and testing requirements
4. Identification of predicate device and demonstration of substantial equivalence
5. Compile and prepare necessary supporting and technical documents
6. Accurately and promptly responding to FDA queries
7. Reviewing marketing materials, labels, and user manuals for compliance and consistency
8. Ensuring adherence to essential requirements
9. Implementing, adjusting, and maintaining a robust quality management system (usually ISO 13485) to meet European or FDA standards as applicable
10. Conducting risk assessment and management per applicable guidelines
11. Providing application submission guidance and support throughout the process
12. Acting as a communication bridge between the client and regulatory officials
13. Developing effective vigilance and post-market surveillance procedures post approval
14. Our support does not end with successful CE mark certification or US FDA 510(k) clearance. We also provide post licensing support, helping our clients with license renewal or staying compliant with updated and latest guidelines.

For guidance on CE mark and FDA approval, feel free to drop an email at [email protected] or call/Whatsapp on 9996859227.