Regulatory approval could actually be an untapped area for found time and money when it comes to getting medical devices to market. That’s right, the very thing that many blame for slowing down the whole time-to-market process could actually be a good thing.

As the Medical Device Program Manager at the National Standards Authority (NSAI) of Ireland in Dublin, I have extensive experience helping clients obtain CE Markings for their medical devices so they can sell them in Europe. But requirements for getting FDA approval can be similar. While gaining a CE Marking doesn’t automatically mean you can get approval by the FDA - or vice-versa - the data and information you use to get either approval will often be the same. By working with your notified body and letting it review the documents, easy-to-fix errors can be discovered and fixed. It sure beats having to wait weeks only to be told that your official application contained avoidable omissions and having to then go back and fix the problems.

I started to see the rise in popularity of pre-submission evaluations with CE Markings over the last year-and-a-half, after the European Union strengthened the requirements for clinical evaluations of medical devices one-and-a-half years ago. While the EU tightened the restrictions on companies being able to put off a clinical trial in favor of citing existing clinical data, it also was more explicit about how a medical device should be approved. Its MEDDEV 2.7.1 Rev 3 document, issued in late 2009, offers an excellent roadmap for how companies can work with Notified Bodies to get a product approved. By using this document as a guide, organizations such as NSAI have been able to help companies “get their ducks in a row” before formally submitting their technical file to support their application, resulting in much more definitive turnaround times.

Here are some tips for speeding up your CE Marking approval as well as almost any other regulatory approval.

Know the process. It sounds simple but understanding exactly what a clinical evaluation is and what the process for approval is will help you better prepare and respond to questions. For a CE Marking, we follow a five-step process that is outlined in the MEDEV document:

1. Identify the scope of the clinical evaluation. Are there any design features of the new device that requires specific attention to certain populations? The more new features, the more information you’ll need to provide.

2. Identify any clinical data that is used for existing devices that can be relevant to the new device and its intended use. This can be tricky because companies often will try to cite data and avoid having to stage a clinical trial. More about that later.

3. If yes to number two, then evaluate that data in terms of its suitability for establishing the safety and performance of the device.

4. If the existing data is insufficient, you’ll have to generate any clinical data needed to address outstanding issues, typically through a clinical trial. Additionally, if the device is high risk (based on new technologies with little track record) or creates a new clinical use for an existing device, you will need to perform a clinical trial regardless of what data is on the market.

5. Bring all the clinical data together to reach conclusions about the clinical safety and performance of the device. If there are any gaps, go back to #1 and restart the process to fill in the holes.

Be honest about the need for a clinical trial. As stated in steps two and three, while a company can use existing data to support the safety and performance of its new medical device, oftentimes there will be holes that need to be filled with a clinical trial.

No one is thrilled at the prospect of having a clinical trial for their product because of the cost and time involved. But if you think about it, a new medical device should offer new benefits to the marketplace. To obtain these benefits there may be risks involved or the product may do things that other devices have never done. So while a company can follow the ‘literature route’ by citing existing data in the marketplace for much of what a new device can achieve, the company should also plan on at least a limited clinical trial to fill in those gaps of existing data and new data required to certify the device. The less a company resists this idea, the quicker they can start the trial and be done with it. And remember, all the data you acquire from your clinical trials may be applicable to other regulatory applications.

Use an expert. When doing your pre-submission assessment, you really need to have it done by someone who is an expert in the field represented by the medical device.

Ask yourself, “Am I choosing this person to evaluate the information because I know that they are an expert or because they’ll give me the answers I want to hear?” Whomever you choose to do the evaluation they should be suitable and qualified in the particular industry the medical device is designed for. They should know how your device will be used and the methodology behind it. Choose to work with someone who is up-to-date and knowledgeable in your particular industry. Trust me, it’ll get you better results and speed up the formal review of your technical files.

You want questions. Lots of questions are good sign of a quality pre-submission evaluation. This means the technical file manager is really doing her job and looking at the technical file.

To speed up the process you need to have a report that will stand up to not only the initial evaluation, but will be correct even after the technical file is approved. What many people don’t understand is the Notified Body is assuming a lot of risk by granting a CE Marking to a product. Our name and Notified Body number are right there with the CE Marking of conformity. We are essentially saying “yes, this device is safe to use.” If it turns out that product isn’t safe, the path will lead back to the auditor and the Notified Body to determine how an unsafe device ever received approval. So the more data you can show that demonstrates the tests of the product and the more you are peppered with questions during the pre-submission evaluation the better. That just means smoother sailing and faster approval when the technical file is formally submitted for review and approval.

The thing is, while many companies see Notified Bodies as a necessary evil, the relationship need not be antagonistic. By working together to assure that all the pieces of the puzzle are there and organized, the final submission will be smoother and approval will be faster, resulting in faster time-to-market. When that happens, businesses profit and life-saving products proliferate. In short, it’s a win-win.