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Claire McKenna

FDA Compliance

Speed Up Your Medical Device Time to Market

Consider a presubmission technical file evaluation

Published: Thursday, February 10, 2011 - 15:11

In business there’s a saying: Time is money. The more time it takes for something to get done, the more money is wasted. Companies that can figure out a way to compress the time it takes for something to happen can realize significant cost savings and also get their products into the market faster, beating the competition and increasing their market share. For manufacturers of medical devices, the part of getting a product to market that most often is blamed for slowing the whole process down—regulatory approval—may actually be one of these untapped areas for found time and money.

There’s no doubt about the fact that the approval process for something like the CE marking for a medical device can sometimes bog down the process of bringing a product to market. However, companies using a presubmission evaluation for their technical file are realizing a quicker approval process and getting their products into the market faster. By having some regulatory guidance before finalizing the technical file, a company can easily avoid having to wait weeks only to be told that their application contained avoidable omissions.

Presubmission evaluations have become very popular during the last year and a half, since the European Union (EU) strengthened the requirements for clinical evaluations of medical devices. While the EU tightened the restrictions on companies being able to put off a clinical trial in favor of citing existing clinical data, they also were more explicit about how a medical device should be approved. The MEDDEV 2.7.1 Rev 3—“Clinical evaluation—A guide for manufacturers and notified bodies” that was issued late in 2009 offers an excellent road map for how companies can work with notified bodies to get a product approved. By using this document as guidance, notified bodies such as the National Standards Authority of Ireland (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.

MEDDEV 2.7.1 Rev.3 contains a lot of useful information that is geared to both manufacturers of medical products and notified bodies who review applications and supporting technical files. By following these guidelines the process of a CE marking approval is greatly accelerated.

So what are some tips to help a company speed up the approval process? Aside from becoming familiar with the 2.7.1. Rev 3 document, the rest revolves around being knowledgeable and open to honest critique.

Know the process. It sounds rather simple but understanding exactly what a clinical evaluation is and what the process for approval is will help you to better prepare and respond to questions. NSAI, for instance, follows 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. Is there 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 often companies 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), creates a new clinical use for an existing device, or is implantable, or a Class III 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 No. 1 and restart the process to fill in the holes.


Be honest about the need for a clinical trial. As stated in steps No. 2 and 3, while a company can use existing data to support the safety and performance of its new medical device, often 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.

Use an expert

When doing your presubmission 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 for which the medical device is designed. 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. It’ll get you better results and speed up the formal review of your technical files.

Lots of questions are a good sign of a quality presubmission 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 that the notified body is assuming a lot of risk by granting a CE marking to a product. They 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 presubmission evaluation the better. That just means smoother sailing and faster approval when the technical file is formally submitted for review and approval.

In the cut-throat world of medical devices, one can understand why presubmission evaluations are catching on in popularity.

Many companies see a notified body as a necessary evil, but this doesn’t mean the relationship has to be antagonistic. By working together to assure that all of the pieces of the puzzle are there and organized, the final submission will be smoother and approval will be faster, which will mean a faster time to market. When that happens, businesses are more profitable and innovative products get into the market to save more lives—a win-win for everyone.


About The Author

Claire McKenna

Claire McKenna is the medical devices program manager with the National Standards Authority of Ireland (NSAI), one of the world’s leading notified bodies. Based in Nashua, New Hampshire, she can be reached at Claire.mckenna@nsaiinc.com or (603) 882-4412.