US vs EU Medical Device Regulations: What is the difference?

You may be wondering whether or not you should pursue putting your medical device on the market in Europe or the United states first. While it is understood that the United States and Europe are two of the largest medical device markets, their regulatory requirements differ. In this blog we will briefly discuss the differences between the two markets from a regulatory standpoint and what you should expect if you are trying to get your medical device approved in either. 

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Medical Device regulations in the United States - Code of Federal Regulations

Medical devices are under the regulation of the U.S. Food and Drug Administration (FDA) in the United States. The FDA classifies medical devices into three categories based on their level of risk: Class I (low risk), Class II (moderate risk), and Class III (high risk). Regulatory control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval (PMA). Some newer medical device types may require a special application process called De Novo. A description of device classification and a link to the Product Classification Database is available at "Classification of Medical Devices."

This may be confusing but the different types of medical device application pathways (510(k) vs PMA vs De Novo) all intend to do the same thing, show you meet the US regulatory requirements (the Code of Federal Requirements or CFR). Generally, your requirements are based on your risk classification and your FDA product code. Looking up your FDA product code in the FDA’s product code database will greatly help you determine what types of regulations apply to your type of device. 

For example, if your product is “GMP Exempt”, it is exempt from good manufacturing processes and in turn can be marketed in the US without having a quality management system. Specifically, these devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892.  Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).

Once you determine your device classification and requirements, submit your application and register your device with the FDA. Once a device is cleared or approved for marketing, manufacturers are required to monitor the device's performance and report adverse events and other issues to the FDA. The FDA also conducts inspections of manufacturing facilities to ensure that devices continue to meet regulatory requirements.

Medical Device Regulations in the European Union - MDR 2017/745

In the EU the process is similar but there are some very clear differences. Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. In much the same way as the United States, the EU Medical Device Regulations (MDR) classify medical devices as Class I (low risk), Class IIA and IIB (moderate risk), and Class III (high risk). 

All medical devices must undergo a conformity assessment to demonstrate they meet regulatory requirements to ensure they are safe and perform as intended. In some cases with Class I devices, manufacturers may self-certify to declare and forego a formal conformity assessment. Undergoing a conformity assessment is what gives medical devices their CE (Conformité Européenne) mark and allows them to be marketed in the EU. 

The conformity assessment usually involves an audit of the manufacturer's quality system and a review of technical documentation from the manufacturer on the safety and performance of the device. EU Member States designate accredited notified bodies to conduct conformity assessments. Notified bodies essentially act as third parties to audit medical device information to ensure they properly meet regulatory standards to be on the market in the EU and are located across Europe and Internationally. They can be found on the NANDO database.

The EU MDR regulations require a conformity assessment in an equivalent manner as the US FDA requires 510(k) and PMA applications. As such, the process is similar. You would determine a risk classification for your medical device, submit to a notified body for a conformity assessment, and obtain a CE mark for your product. At this point, you are required to monitor your device for performance and safety and report any issues to relevant regulatory authorities. 

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What are the main differences?

When you are creating a medical device that you wish to put on the market, there is one thing that is true for every location you intend to market it: the product should be safe for use and perform when used as intended. Generally, this is what the CFR in the USA and the MDR in the EU intend to enforce. Many consider the US regulations to be less stringent than the MDR 2017/745 regulations in the EU. This is due to a few key focus areas of the MDR which include the requirement of a comprehensive clinical evaluation and QMS for all medical devices (FDA has many GMP exempt devices) for all medical devices. Strategically developing your product so that you meet both EU and US regulations saves time, money and ensures your product is of the highest quality for your users.

We are still discovering how the medical device conformity process looks under MDR. The EU has been transitioning all medical devices into MDR with a deadline that has just been extended into 2028, depending on device class, due to lack of capacity of notified bodies and manufacturer preparedness in meeting regulations. As the MDR transition continues, we learn more about the best way to meet the conformity requirements.

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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.