Which Regulatory Requirements Apply to My Medical Device?

 In Design Strategy, Medical Product Design

The medical device industry is highly regulated. For good reason. These regulations exist to protect patients and consumers by ensuring the safety and efficacy of medical devices.

Of course, medical device companies want to produce devices that are safe and effective. But they don’t always know how to navigate the muddy waters of regulatory requirements. Even seasoned medical device professionals often find it challenging to figure out which of the many regulations their planned device is actually subject to.

The stakes are high when it comes to meeting the government’s regulatory requirements. The FDA (and other governing bodies) won’t approve your medical device until you’ve crossed every “t” and dotted every “i.” And you’ll be held accountable to all the pertinent regulatory requirements — even if you weren’t aware of them. So it’s critical that you assess your medical device early in the planning process to determine which regulations will apply to you. Here’s what you need to know to get started.

Understanding Your Regulatory Obligations: What’s at Stake

The regulations governing your medical device will likely impact your development process in a number of ways. Adhering to regulatory guidelines will typically influence and shape the design of your device. Additionally, they will almost certainly affect how you test your device and document your activities.

If you aren’t aware of the regulatory requirements that apply to your project at the outset, you could put your entire project at risk. After all, you are subject to all the applicable regulatory requirements whether you know about them or not. One can’t go to market with FDA approval until you’ve satisfied those obligations. In turn, if you don’t get it right the first time, the result will be wasted time and money.

It’s important to note that your product’s initial approval and launch are only the first steps when it comes to regulatory compliance. Over the course of your medical device’s lifespan, you will need to remain current with all regulatory requirements. Meaning, you’ll need to comply with them at all times.

Knowing what’s at stake is a key aspect in early product development. The FDA has the power to audit your products at any time, not just within a year of launch. If you are not in compliance, the FDA can hit you with hefty fines or penalties.  They can demand that you recall products or stop sales altogether until you are in compliance. So what’s at stake, only you can decide!

Which Regulations Apply to My Device?

There’s no one-size-fits-all answer to the question of which regulations will apply to your medical device. In fact, the process of figuring out which standards you need to comply with can be tricky. For example, the FDA’s standards are broad, and each one covers a range of topics. In fact, it’s not uncommon for a standard to have many of sub-standards. And depending on where you plan to sell your device and how your users will interact with it, you may need to consider several other governing bodies in addition to the FDA. Determining where your device fits in requires both expertise and discernment.

However, it is possible to identify the main factors that determine which regulatory requirements your product may be subject to. These include:

  • Your device’s classification. The FDA groups medical devices into three classes based on the device’s level of risk. Class I medical devices — such as bandaids and braces — carry the least amount of risk to patients and are therefore subject to fewer regulations. Class II, which represents a slightly higher level of risk, represents the majority of medical devices. Examples include prosthetic’s too diabetes infusion pumps. Finally, Class III devices are the most invasive (think pacemakers and artificial hearts) and subject to the highest degree of scrutiny in the form of regulations. This makes logical sense. If regulations are in place to mitigate a medical device’s risks, then it follows that the riskiest devices would be subject to more regulations.

  • Where you plan to go to market. The regulations your medical device is subject to will depend on where exactly you plan to sell your device. If you plan to sell your device in the United States, then the FDA is the main governing body. And if you plan to go to market in Europe, the Middle East, Africa, and/or Asia, you’ll need to comply with the International Organization for Standardization (ISO).

  • Your device’s components. Will your device be electrically wired? Might it contain batteries? What about software, LEDs, or lasers? Are any of the components in your device disposable? Your device’s physical attributes and components may trigger component-specific regulatory standards.

  • Your device’s interaction with the human body. The specific ways that your device interface with the human body may dictate which regulations you must adhere to. For example, a device that touches a user’s skin is typically less risky than a device implanted in a patient’s body.

  • Your device’s environment.  You may be subject to regulations depending on where your device will be used. For example, devices intended for use in hospitals are treated differently than those intended for use in homes. Other aspects of your device’s intended environment — such as whether your device will be exposed to water — may play a role, too.

MindFlow’s Medical Device Regulatory Diagnostic

Many medical device companies struggle to assess which regulations apply to their specific product. It’s no wonder given the level of complexity and nuance involved. Over the years, we’ve accumulated the experience and expertise necessary to accurately discern which regulatory standards apply to a given medical device.

To that end, MPE (Formerly Mindflow) has developed a medical device regulatory diagnostic to guide our clients in identifying their regulatory obligations. We implement our diagnostic in the discovery phase of our work with clients. This enables us to move forward with the medical device development process with full knowledge of the requirements that must be satisfied.

Our diagnostic consists of a series of questions about your device, its intended use, and other applicable factors. We work through the questions with you and then compile a report of all the regulatory standards you’ll need to meet. And we also help you understand what that means in terms of specific requirements to-do items.

Then as we move forward with the development process, we help your team compile the necessary documentation showing that your device is in regulatory compliance. This documentary record becomes a part of your Design History File (DHF), which you submit to the FDA.

MindFlow’s regulatory diagnostic gives you the confidence to move forward with your medical device. And to do so knowing that you are on track to meet the necessary regulatory requirements. That means you’re one (big) step closer to bringing a safe, effective, and successful medical device to market.


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