Can I Certify as Class I First and Do Class IIA Later? 

Can I Certify as Class I First and Do Class IIA Later? 

We have had many clients come to us and ask any variety of the same question: “I think my device will end up being Class IIA but I want to start with it on the market as Class I. Is that even possible?” In this blog article we will answer that question.

Medical devices in the European Union (EU) are classified into different categories based on their intended use and the risks associated with using the device. Device classifications according to the EU Medical Device Regulations (MDR) range from Class I (low risk) to Class III (high risk). For instance, a Class I device could be a software diary to track your diabetes progress, while a Class IIA device could be software that is used to predict diabetic shock using that diary. Changes in the device's design, intended use, or even regulatory updates can lead to a device being upclassified or downclassified, as outlined in MDCG 2019-11. What that means practically is explained in more detail later.

The Difference Between Class I and Class IIA Devices

The primary factors that determine a medical device's classification include the device's intended purpose, the duration of contact with the patient, whether it is invasive or non-invasive, and the potential risks it poses. If we take our example above of the diabetic diary versus the diagnostic tool for diabetic shock, you can see how the diagnostic aspect of the Class IIA device is a more complex clinical use that carries with it more risks to the patient, especially if it should work incorrectly or not at all. The Class I device is not monitoring or diagnosing a condition but reporting raw data for the user. You can see an example of a Class I device on the market here.

Because Class IIA devices carry additional risk compared to Class I devices, they also have more strict regulatory requirements in order to be placed on the market. For this reason, many companies wishing to get their products on the market as fast as possible try to develop their product as a Class I device. However, you can’t just declare your product as being Class I to be designated as a Class I device. Your device classification is dependent instead on what it does and the risks it carries so you would need to design your product with features and a use case that allows it to be a Class I device.

Classification will differ based on the product type. There are two guidances that do a great job of walking through every detail of how device classifications are handled for each type of product. For medical devices look at MDCG 2021-24 for reference and for software medical devices, the MDCG 2019-11 guidance takes it one step further to describe software specific examples.

Self-Certification and the Need for Audits

One of the biggest advantages of developing Class I devices is that most can undergo what is called self-certification in Europe, meaning manufacturers can declare they meet regulations and sell their product without the need for a Notified Body's involvement. These products still need a quality management system (QMS) and technical documentation like other classes of medical devices but can forego the time consuming task of Notified Body audits. One caveat - there is a specialized group of Class I devices that still require an audit in a similar manner to Class IIA and above devices. These are Class I devices with a measuring function, sterilized, or reusable surgical instruments (Commonly referred to as Class Im, Is, or Ir). 

What does this mean in practicality? Since Class I devices don’t need to wait for an audit, they have the potential for a much shorter time to become CE marked as long as they meet all their requirements. However, this doesn’t mean you can skip any regulatory documentation or process steps like setting up your QMS or technical documentation as notified bodies can still request to inspect your information if they choose to (and it does happen!). 

For Class Im/s/r, Class IIA, Class IIB, and Class III, you will need to undergo an audit to confirm that your QMS and technical documentation are up to standard. Typically, this is accomplished by submitting your information to the Notified Body of your choosing, waiting for their availability to audit, and then going through the audit. You should receive your approval for affixing your CE mark at the end and you’re ready to go.

Stop me if you’ve heard this before, but MDCG has a guide for Class I device manufacturers (MDCG 2019-15) giving an overview of the processes to get your product CE marked and on the market. Fortunately, we just released a guide on medical device classification that is much easier to read. 

Transitioning from Class I to Class IIA 

“Can I certify my device as a Class I if it will eventually be Class IIA? Should I just begin my certification as a Class IIA or transition it to IIA later?”

Both of these approaches are possible and have been done many times. There are benefits and downsides to both. 

As mentioned earlier, the benefits to certifying a Class I device is that there is no need for an audit (given it isn’t Im/s/r). By having a less risky version of your device on the market you can gather performance and safety information that may be useful if you do ever need to certify your product as a Class IIA device. 

Class I devices will most likely have reduced clinical functionality compared to Class IIA devices simply due to the fact that Class I devices are required to be very low risk and any serious clinical utility will introduce risk at some point. This may be a downside if you have to strip away all of your product’s main functionalities in order to get its intended use to reflect a Class I device. In this case, going straight for a Class IIA certification will be your best bet.

A Class I device can transition to a Class IIA classification through various product changes, such as modifications that alter the intended use or greatly change its potential risk to users or patients. If we use our diabetes software example above, if the Class I software is modified to include a diagnostic feature for diabetic shock, it may be reclassified as a Class IIA device since its intended use changed. 

If a design change is planned for your device, you should consider first if it changes the class of your device based on the criteria in MDCG 2021-24 or MDCG 2019-11. If the change will upclassify your device, you will need to ensure your technical documentation and quality management system are up to date and submit to a Notified Body for a conformity assessment regarding your product. Once your product has been audited and approved by the Notified Body, you can affix your CE mark and market your new product.

Making Changes to your Medical Device

One thing to remember is that not all product changes necessitate a reclassification or notification to a regulatory body. For instance, a bug fix to Software as a Medical Device (SaMD) usually doesn’t lead to any change in classification or any notifications to Notified Bodies. As part of the quality management system, this process is typically handled according to a manufacturer’s change management process. 

Change management ensures that the impacts of the change to the product are evaluated for their influence on the intended use, regulatory requirements, and risk profile before they are released. This way there is control over how changes are made and their impacts on a device’s MDR classification. 

FormlyAI: Your Partner in Medical Device Certification

At FormlyAI, we understand the complexities of MDR medical device certification. Our service provides a streamlined, efficient path to CE marking and all the tools to ensure your medical device adheres to all necessary EU regulations. All for a fraction of the cost of using traditional consultants. This way you can build your compliance documentation and apply for CE marking in a matter of weeks, not years.  

Learn more about our software and accelerate your path to CE marking with Formly.