Facts about 510k and CE Marking
The most popular regulatory route for marketing a medical device in the US is a FDA 510k. For a device of the same level of risk, a CE Marking is required to market a medical device in the European Economic Area. CE marking means Conformité Européenne or European conformity in French. And as the name suggests, it proves product compliance with European requirements that ensure specific safety, health, and environmental protection standards.
It can be required for several different products. Regarding medical devices, the CE marking allows companies to move and sell their devices across the 30 countries of the European Economic Area once they follow the EU Regulation 2017/746, also known as the Medical Device Regulation.
A 510k is a premarket submission made to the FDA. It is called a 510k because it refers to that section of the Food, Drug, and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device that is currently legally marketed. If the FDA agrees that the device is substantially equivalent, it may be marketed immediately without needing a premarket approval (PMA) submission.
If you’re a manufacturer or specification developer seeking approval for a new medical device, you’ll need to submit a 510k application to the FDA. We specialize in assisting medical device manufacturers and specification developers in efficiently preparing and submitting their 510k files to the FDA, reducing the likelihood of receiving an initial “Refuse to Accept” (RTA)
Crucial Steps in 510k and CE Marking
Understand the key regulatory steps for medical device market access in the United States and the European Union.
| Step | FDA 510(k) Clearance | CE Marking (EU MDR) |
|---|---|---|
| 1 | Determine the product code and classification of the proposed medical device to establish whether the FDA 510(k) pathway applies. | Determine whether the product meets the definition of a medical device under Regulation (EU) 2017/745 (MDR). |
| 2 | Identify an appropriate predicate device with the same intended use and assess substantial equivalence using the FDA 510(k) database. | Determine the applicable medical device classification in accordance with the MDR classification rules. |
| 3 | Identify applicable FDA guidance documents and recognised consensus standards. | Establish and maintain a Quality Management System (QMS), where applicable. ISO 13485 is commonly used to support medical device quality management. |
| 4 | Complete the required performance testing, biological evaluation and, where applicable, clinical studies. Compile the supporting test reports. | Assign a Unique Device Identifier (UDI) where required and complete the applicable device registration requirements. |
| 5 | Prepare the 510(k) submission, including the applicable sections and supporting documentation required by the FDA. | Prepare the technical documentation in accordance with the applicable MDR requirements, including Annexes II and III. |
| 6 | Review the submission against the FDA Refuse to Accept (RTA) checklist to verify administrative and documentation completeness. | Establish and maintain a risk management process in accordance with ISO 14971, as applicable. |
| 7 | Pay the applicable FDA submission fee and submit the 510(k) electronically in accordance with FDA requirements. | Prepare the Clinical Evaluation Report (CER) in accordance with MDR Article 61 and applicable clinical evaluation guidance, including MEDDEV 2.7/1 Revision 4, where relevant. |
| 8 | The FDA conducts an acceptance review, substantive review and, where applicable, interactive review to evaluate the submission. | Non-EU manufacturers must appoint a European Authorised Representative in accordance with MDR Article 11. |
| 9 | If the FDA determines that the device is substantially equivalent to the predicate, it issues a 510(k) clearance decision. | Complete the applicable conformity assessment. Involvement of a Notified Body is required for devices and conformity assessment routes that require it. |
| 10 | Following clearance, the device information can be found in the FDA 510(k) database. Applicable establishment registration and device listing requirements must also be fulfilled before marketing. | Obtain the applicable conformity assessment certification from the Notified Body, where required. ISO 13485 certification is separate and is not universally mandatory under the MDR. |
| 11 | — | Prepare and sign the EU Declaration of Conformity confirming compliance with the applicable legislation. |
| 12 | — | Affix the CE marking to the device and its applicable packaging and documentation in accordance with the relevant requirements. |
| 13 | — | Establish and maintain Post-Market Surveillance (PMS) activities, including applicable vigilance, reporting and post-market follow-up obligations. |
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Validity of CE Certificate and 510k Clearance
CE Certificate to be re-certificated evrey 3 years. For instance, a class IIa device can receive a certificate valid for just three years. Moreover, annual surveillance audits are conducted between certifications
510(k) clearance will not expire and is valid until changes are made to the intended use, the indications for use are altered, or technological characteristics are changed
Working with CE Marking consultants like I3CGLOBAL helps manufacturers prepare and respond to Notified Bodies review queries more efficiently and effectively, ultimately speeding up the CE Mark approval process.
Frequently Asked Questions
Is Substantial Equivalence mandatory for CE Marking?
CE Marking Substantial Equivalence is NOT Aplicable
Is Clinical Evaluation Report mandatory for FDA 510K?
- 100% of medical devices with CE Marking require a clinical evaluation report (CER) as an essential requirement in the technical file
- 10-15% of 510k submissions require clinical studies
Is PMCF (Post-Market Clinical Follow-up applicable for both?
- 100% recommended only for most devices in CE Marking
- recommended only for high-risk devices in 510k submissions
Is QMS applicable for both?
- Must finish QMS before CE Mark submission
- Not mandatory during submission 510k submissions
Is Risk Management applicable for both?
- Recommended for moderate to high-risk devices only in 510k
- Mandatory for all devices IN CE Marking