To successfully get a medical device to market, there’s a complex network of reporting, testing, certifications and submissions that need to be completed. And then there’s the paperwork that follows in order to prove the results.

All this is done in the name of safety and effectiveness. A medical device has the potential to cause harm if not carefully designed and thoroughly investigated.

One certification in particular often trips medical device companies up: the International Electrotechnical Commission’s 60601-1 standard. That’s because it seems like just one standard, but a lot lies beneath its surface.

The IEC 60601-1 device certification is an important requirement. And companies know this: They often include it on their product requirements document. It’s wise to include 60601 in the PRD — you can’t sell a medical device without it. The mistake is not understanding what an undertaking it truly is.

What Is IEC 60601-1 Certification?

IEC 60601-1 is a technical standard that medical electrical equipment and devices must meet to be considered safe and effective before they go to market. It’s required for FDA approval, and devices must meet the standard to be sold in the United States and Europe.

Simply put, without this certification, you won’t be able to get your product into the market.

But let’s dive deeper into the specifics that it requires.

Standards and Requirements Medical Device Companies Should Know

Device manufacturers already have to adhere to two major standards for quality management: ISO 13485 and FDA 21 CFR 820.30. Those two standards refer to the management system and processes that prove device manufacturers can meet customers needs and regulatory requirements.

Beyond that, there are standards for the devices. The IEC 60601-1 standard is an umbrella that encompasses 100 additional standards, all which play a role in this certification. The onus is on the company or developer to understand which standards are applicable, and therefore necessary, to achieve before the product can go to market.

Start by identifying where your product will be sold and shipped. That will impact the specific standards that are applicable. Each region has different versions with slightly varied requirements:

If your medical device will be shipped to multiple countries, adhering to the most stringent standards ensures you won’t hit a snag.

There are five foundational standards that almost always apply — 60601-1 and four others.

The Big 5: Basic Requirements

  1. IEC 60601-1 is the basic standard that refers to the minimum safety and performance required of a medical device before it can be sold. The other individual standards each apply to different and highly specific aspects of your device. Each standard requires its own process, test, or evaluation.
  2. IEC 60601-1-2: Emissions and Immunity measures safety and effectiveness of electromagnetic compatibility of devices. For example, on a laptop, a ferrite is a small piece of hardware that suppresses electromagnetic frequencies emitted by the charger. Without that piece of equipment, your charger is akin to an antenna, broadcasting a radio wave. In a medical setting, that can be extremely dangerous if a signal interferes with another device.
  3. IEC 60601-1-6 and IEC 62366-1: Usability is a standard intended to prove that users can operate the device without harming themselves or the patient. The FDA considers IEC 62366-1 as the international standard for human factors engineering (HFE) in medical device development. The term usability encompasses any users of the device, like doctors, nurses, patients or people outside of a clinical setting with no medical experience, and typically requires summative usability validation testing.
  4. ISO 14971: Risk Management is a process your team must follow to identify hazards and prove how you will mitigate them. Hazards vary, and this process will document them by severity and probability of occurrence to find a rating. Then your team must prove the design mitigates these risks.
  5. IEC 62304: Firmware or Software is a standard that applies to the process of creating software and ensuring it meets basic safety and effectiveness standards and appropriately manages risk. The requirements for this standard are typically done in partnership with the software team to ensure security and any potential glitches or defects are addressed.

Together, these make up the five most important standards, but there’s more to consider based on your specific device.

Device Components Affect the Certification

Medical devices are categorized based on intended use and level of risk.

Depending on your device, different standards will apply based on the components of the device itself. These can include but are not limited to:

  • Batteries
  • Wireless components
  • Labels
  • Devices with components that touch the body
  • Cleaning, sterilization and disinfection procedures
  • Packaging and shipping materials
  • Electrostatic discharge immunity
  • Enclosure protection from fluids and dust
  • Devices that contain sensitive patient information

The above list is not exhaustive but shows how the different components of your device will affect the way you carry out the certification requirements. Every test, report, evaluation and assessment you conduct needs to be listed in the design history file (also known as a technical file.) This file includes all the applicable reports and is submitted to the FDA when it’s time for approval.

The realm of requirements feels limitless. But it’s not — you just need to understand your device at a granular level and analyze exactly which requirements apply.

4 Considerations for a Successful Certification Process

Like much of medical device development, certifications can’t be isolated from the process without risking the final outcome and creating unnecessary time and budget expenditures. The certification process needs to be carefully planned for and integrated into the design process from start to finish.

To make the 60601 certification process run smoothly, and to achieve the best final result, keep these four considerations in mind.

1. Seek advice from a compliance expert.

Your design team and other experts all have an area of prowess. To start your project out on the right foot, talk to a regulatory and compliance expert about the specific requirements for your product.

The requirements and standards you must meet change based on the product you are developing. The requirements also change over time — and an expert will know what’s coming and how to plan for a years-long development process.

The result of speaking to a compliance expert is that you’ll come away with a complete list of everything you need to meet for a successful product launch.

2. Create a project plan.

Next, your team needs to take all of the information you learned from the compliance expert and integrate into a comprehensive project plan. Developing your medical device will include hundreds of tasks, many of those directly related to the IEC 60601-1 certification.

A project plan identifies each step of the process, every task involved and all of the associated costs. This gives you an accurate timeline and allows you to plan ahead for certifications and requirements.

For a complex medical device, like a ventilator, the development process will take years. A project plan guides your process and ensures your team is in lockstep the entire time.

3. Write test plans early.

Once you’ve created a detailed project plan, it’s time to incorporate your test plans.

These tests will typically take place at an external lab. In the current market, test-lab-scheduling lead times are about three months. If you’ve waited until the last minute, you’ll be looking at a long delay. And you’ll likely scramble for the first appointment you can get.

The team at the test lab will generally write a detailed test plan for you. It’s important to think of the test lab as an extension of your development team, and to not just find any test lab, but to find the right test lab. Thoroughly vetting test labs ensures you will find one that meets all your needs and helps you understand testing expectations.

4. Pre-test your prototypes.

As the development process moves forward, pre-testing prototypes at every stage is vital.

Think of preparing for the certification like a lawyer prepares for a trial. A good lawyer won’t ask a question in the courtroom if they don’t know the answer. The same is true for your medical device.

The last stage of testing for the IEC 60601-1 certification will happen with the final manufactured device. It’s expensive to get to that stage and wonder if it will pass. By testing at every step, you will be confident of the result before you complete the test.

IEC 60601-1 Doesn’t Have to Slow You Down

Like almost every aspect of medical device development, slowing down at the beginning actually accelerates your process in the long run.

IEC 60601-1 and all the other standards that it includes are vital to your device’s success. It’s just one short line in your PRD, but it can cause months of lost time and money if you don’t properly plan ahead.

When you start the process properly by consulting a compliance expert, meticulously planning, and scheduling tests in advance, you’ll avoid speed bumps on your road to FDA approval and product launch.

The 60601 race is about endurance, not speed. Smart, strategic planning always wins in the long haul.