Combining a 510k Submission with CE Marking: 9 Sections that are Duplicated
This article explains how to reduce your workload by at least 35% if you integrate your two project plans for a 510k submission and CE Marking into one comprehensive regulatory plan.
My first medical device regulatory submission was for CE Marking, while my second regulatory submission was for a 510k submission of the same product. This is a very common path for medical device regulatory submissions, but it is also an inefficient path. If you know that you will be submitting both types of documents, then you should plan for this from the start and reduce your workload by at least 35%.
The reason why you can quickly reduce your workload is that there are nine key sections in both submissions that are very similar. Therefore, you can write the content for those nine sections in such a way that the material can be used for your 510k submission and CE Marking.
9 Sections are Duplicates
Here are the nine key sections that the two types of regulatory submissions have in common:
- Device Description
- Sterilization & Shelf-Life
- EMC/Electrical Safety
- Bench Testing
- Animal Testing
- Clinical Testing
There are 20 sections required by the FDA for a Traditional 510k submission, but often some of the sections are boiler plating, and other sections do not apply to the device being submitted. A few sections are unique to a 510k submission, such as:
- Substantial Equivalence
- 510(k) Summary
- User Fee Cover Sheet Form 3601 & Submission Cover Sheet Form 3514
- Declarations of Conformity on Form 3654
- Table of Contents
Technical Files for CE Marking also have a few unique sections, such as:
- Essential Requirements Checklist
- Classification Rationale
- CE Marking Application to Notified Body
- Declaration of Conformity
- Table of Contents
How to Construct Your Plan
In one of my previous blogs, I explained how I use the 510k Table of Contents as a project management tool for a 510k submission. You can do the same when you are constructing a combined plan for a 510k submission and CE Marking. The first step is to create the same kind of project management tool I use for a 510k submission (i.e., a Table of Contents) to manage your CE Marking Technical File. I recommend preparing your Technical File in accordance with the GHTF guidance document released by study group 1: N011:2008. This guidance mirrors the format that will be required in Annex III of the new European Medical Device Regulations that should be released next spring. I do not recommend using the NB-MED 2.5.1/rec 5 guidance document. Even though the content is similar to the GHTF guidance, the format is quite different. After I have two separate project plans organized in accordance with the Table of Contents, then I merge the two plans on a spreadsheet and consolidate the duplicate sections.
Scheduling Tasks & Project Management
If you are going to outsource sections of either submission, these nine sections should be written and reviewed by someone familiar with both types of submissions. The headers and footers will be unique to the type of submission, but I write the text in Google Docs without formating for ease of sharing and so I can use my Chromebook.
If you have an in-house team that prepares your 510k submissions and Technical Files, you might consider training the people responsible for each section on the requirements for each type of submission. This eliminates rewriting and reformatting later. I like to assign who is writing each section in a separate column of my Table of Contents planning tool. Then I will sort the sections by the expected date of completion. All the safety and performance testing, and any sections requiring validation, will typically be finished at the end of the project. Therefore, it is important to dedicate unique resources to those sections rather than asking one person to write several of those sections. You also will want to make sure any supporting documentation they need is completed early so that the project’s critical path doesn’t change. I typically use a Chromebook spreadsheet for all of this, because 20+ sections are just too few tasks to warrant the use of Microsoft Project or some other Gantt Chart planning tool. If you keep it simple, more of your team will read it and update it frequently.
RA Consulting Tip
I have several PCs (laptops and desktops of various vintages), but nothing is faster for writing plain text than a Chromebook. Then I export documents to Word format and work on tables and formatting of the information as needed. I can also jump on any computer with an internet connection and work on my documents. This enables me to travel very light when I need to. If you are a tablet user, there are some other solutions I prefer–such as Evernote.
Additional 510k Training
The new 510k book, “How to Prepare Your 510k in 100 Days,” ships on Monday, February 6th, 2017. There is also an on-line 510k course series consisting of 24 webinars. Please visit my webinar page to purchase individual webinars. We also have live 510k workshops.
Posted in: 510(k)Leave a Comment (3) ↓
I believe a Risk Assessment is required for CE Marking.
Also not all CE Marked medical devices require a Notified Body.
A good started comparison.
Thank you for your comment Ted. Yes, a risk management file is required as part of every Technical File and Design Dossier for CE Marking. You are also correct that Class I devices that are non-sterile, non-measuring do not require a Notified Body. This is also true for 80% of the IVD products at this time.
Typically companies will write a STED that is a risk management summary report and the STED will reference all the other documents and risk management activities that were part of the risk management file. Most Notified Bodies just review the summary, but sometimes they will go into depth and review specific documents that are referenced. However, I recommend just providing the summary with references to the other controlled documents.
For a 510k submission, you only need to include risk analysis for software devices for moderate or high level of concern. Other products do not require risk documentation in the submission. Risk management is still a requirement for design controls and risk management is an input into design. In fact, I have used a CE Marking STED as the starting point for a PMA submission of a combination product. PMA submissions require information about risk management activities in a summary format and the CE Marking STEDs have almost everything you need to prepare that section of the PMA.
The only other caution is to make sure that you are compliant with the EN version of ISO 14971 (2012 version), because your Notified Body will require you to address the 7 deviations in Annex ZA, ZB & ZC.
Thank you Rob. For a recent project just completed, I had a device that had the CE mark but the client is looking for FDA approval. Great information as to where prioritize the requirements fulfilled and identify the potential gaps.