Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.

Fortunately, compliance with medical device regulations and standards is not an impossible task. A companywide emphasis on quality, along with the right tools for the job, can ensure that you stay compliant and produce the safest, most effective medical devices possible.

Here’s what you need to know about compliance in the medtech industry.

What is medical device compliance?

Medical device compliance refers to the way a company meets the requirements of all applicable regulations and standards. Medical device compliance should begin during design and development, and must be maintained throughout the entire life cycle of the device.

The cornerstone of every medtech company’s compliance efforts is its quality management system (QMS). The QMS is a formalized system that documents the policies, procedures, documentation requirements, and processes that medtech companies use to ensure that their products are both safe and effective for the end user. The QMS is also how companies demonstrate to regulatory agencies that their approach to quality management is in compliance with all applicable requirements.

What are some of the most important regulations and standards for medtech companies?

Creating and maintaining a compliant QMS can seem overwhelming at first. But the regulations and international standards that exist aren’t there to make life difficult; they exist to give you a road map to compliance.

So, let’s look at some of the most common (and useful) regulations and standards you’ll need to know as you work to achieve compliance. (Keep in mind, these are some of the most widely applicable regulations and standards. If you’re interested in knowing what additional standards may apply to your specific device and market, check out our Guru Services.)

21 CFR Part 820 is the regulation that governs quality systems for medical device companies in the U.S. A quality management system is required for any medical device company in the U.S., even those with low-risk devices, and Part 820 provides the requirements you must meet to keep your QMS compliant in this region.

21 CFR Part 11 is the regulation that lays out the circumstances under which the U.S. Food and Drug Administration (FDA) will accept electronic records, electronic signatures, and handwritten signatures executed to electronic documents. Part 11 should be on every medtech company’s radar because managing quality processes or clinical activities on paper is time-consuming and error-prone—but generic software like Excel is not Part 11-compliant. Any electronic solution you use for records or signatures should come validated to 21 CFR Part 11 to give you peace of mind that you’re compliant with the regulation.

EU MDR, the European Union’s Medical Device Regulation, governs the marketing of medical devices. It’s extensive, taking a more granular approach to compliance than 21 CFR Part 820. Keep this in mind if you’re considering putting a device on the market in the EU. The EU In Vitro Diagnostics Regulation (EU IVDR) is MDR’s sister regulation, and while it’s similar in structure and content to MDR, IVDR governs the marketing of in-vitro diagnostics.

ISO 13485:2016 is the global standard for medical device quality management systems established by the International Organization for Standardization (ISO). ISO 13485:2016 is not a regulation. However, compliance with the standard is required for medtech companies that want to market products in the EU. On top of that, the FDA is currently in the process of harmonizing 21 CFR Part 820 with ISO 13485:2016 (the new QMSR). So, after February 2026, all medical device companies marketing in the U.S. will also need to comply with this standard.

ISO 14971:2019 is the global standard for the application of risk management to medical devices. The standard exists to help medtech companies identify potential hazards, evaluate their associated risks, and control those risks. Although ISO 14971:2019 is a standard, risk management is a regulatory requirement. Moreover, ISO 13485:2016 refers to ISO 14971:2019 directly, and it’s expected that medtech companies will take a risk-based approach to product development.

ISO 14155:2020 is an essential standard for medtech companies that must perform clinical investigations on their devices either to gain regulatory approval or drive market adoption. ISO 14155:2020 is the global standard for good clinical practice (GCP) in clinical investigations of medical devices for human subjects. The principles it lays out are critical to protecting the safety and rights of patients, as well as collecting reliable, credible clinical data.

Three reasons why every medtech company needs to prioritize compliance

It’s worth taking a step back and considering why we have these regulations and standards in the first place, and why it’s essential that we follow them throughout the life cycle of our devices.

1. Patient safety

The safety of patients and other end users is the single most important reason to prioritize medical device compliance. None of us want a loved one to use a device that was designed haphazardly or manufactured without appropriate controls in place.

I want to emphasize here that basic compliance with regulations will not guarantee a high-quality device. This is especially true when compliance is treated as a “check box” activity where the goal is to do the bare minimum to get to market. But by following the best practices for medical device design, development, manufacture, and postmarket surveillance that have been codified by regulatory bodies, you stand a much better chance of producing a device that is both safe and effective for patients.

2. Regulatory approval

Of course, if you can’t get your device approved by regulatory agencies, then even a great device will never be able to help patients. Staying compliant with regulations and standards is also important if you want to get your device to market. This may sound obvious, but companies that receive warning letters often spend years attempting to fix the situation.

If your company doesn’t have the financial runway to spend years under a warning letter, then focusing on compliance should be a top priority. Remember, the costs associated with quality are worth the investment when compared to the costs associated with audit findings.

3. Economic viability

Again, although compliance isn’t necessarily an indicator of quality, it does require your business to perform certain activities and operate in a way that is far more likely to lead to high-quality products.

Performing activities like design controls or risk management—or having processes in place for training, supplier management, CAPAs, and complaint handling—will help ensure you catch potential problems before they occur. A seemingly great device might not be as profitable as it could be if compliance isn’t a priority for the company.

If you’re still feeling overwhelmed by the idea of complying with medtech regulations and standards, you don’t have to do it on your own. Greenlight Guru Quality was built specifically for medtech companies, which means it comes prevalidated per the requirements of 21 CFR Part 820, Part 11, EU MDR, ISO 13485:2016, and ISO 14971:2019. The software provides what you need to become compliant and stay that way.

Published Nov. 20, 2024, in the Greenlight Guru blog.