This webinar will help you combine a 510k submission with CE Marking for a comprehensive regulatory strategy for your medical device launch.
In this webinar, “Combine a 510k submission with CE Marking technical files”, you will learn the basic changes made to the 510k submission process by implementation of the FDA eSTAR template and the changes to the CE Marking process resulting from Regulation (EU) 2017/745 entering into force. The elements of each submission type that were common to both submissions in 2015 have not changed, but the FDA eSTAR template has made the 510k submission simpler, while technical files have become far more complex.
There are 20 sections required by the FDA for a Traditional 510k submission, and the organization of the CE Marking technical file is totally different. Testing requirements for the USA and Europe are quite similar, but the presentation of the testing data is nothing alike. The FDA prefers to receive full testing reports, while Notified Bodies require a summary technical document (STED). Therefore, you are able to submit a 510k to the FDA immediately after the last testing report is completed. In contrast, CE Marking requires that you prepare a STED that summarizes each testing report prior to submission. This creates an inherent delay prior to the submission of a technical file.
The device description requirements for both types of submissions are very close. Therefore you can use a single controlled document for the device description in both submissions. Most of the boilerplate sections are unique to the type of submission and you cannot repurpose your content for those sections. The CE Marking technical files, however, require additional technical content beyond the requirements in a 510k submission:
- Risk classification rationale
- Declaration of Conformity
- Reference to similar and previous versions of the device (located in our device description)
- Manufacturing process flow & manufacturing site certifications
- Risk management file
- Summary of design changes
- State-of-the-art & clinical evaluation report
- Notified Body application for CE Marking
- ISO 13485 Certificate
- PMS Plan & PMCF Plan
In addition, to the technical content required for a CE Marking submission, Notified Body auditors also have to verify the following elements during the audit process:
- quality system documentation (only sampled during FDA inspections–not during as part of the 510k process)
- supplier agreements and supplier auditing may be conducted, depending upon the ISO 13485 certification of the suppliers
- training effectiveness and competency of employees
- suitability of the infrastructure and work environment for manufacturing your medical device
This webinar includes the following:
- Project management tools and templates
- Comparison of 510k and Technical File requirements
- References to US & European guidance documents
- Suggested timing for the overall combined regulatory plan
When was this webinar on how to combine 510k submissions with CE Marking technical files created?
This webinar was initially hosted live in 2015, and we re-recorded the webinar on April 4, 2022. The updated webinar now includes revisions to the 510k process to reflect the implementation of the FDA eSTAR template and changes to the CE Marking technical file review process resulting from Regulation (EU) 2017/745 coming into force in 2021.
Who should watch this video?
- Regulatory Affairs
- Product Development / R&D
The webinar provides an overview of the 510(k) submission and CE Marking processes. We explain which parts of the submissions are similar where you can repurpose content from one submission for the other. We identify changes to the 510(k) process resulting from the implementation of FDA eSTAR templates. We identify changes to the CE Marking process resulting from the implementation of the MDR. Finally, we explain why these changes have shifted the entire medical device industry from a European market first strategy to a US market first strategy.
When you purchase this webinar, you will receive a copy of the native slide deck and a link to download the recording. If you have questions about your 510k submission or CE Marking technical file preparation, you can schedule a call with Rob Packard using our calendly link on the Contact Us page. If you decide to purchase the 510k course at a later date, we will give you a credit for any of the paid webinars in the 510k course series that you have already purchased.