When you go to the hospital for a health issue, you expect that the doctors who treat you are both qualified and capable.

However, most people don’t consciously have the same expectations towards the medical devices used to diagnose and treat them – even though their role is just as important. 

When it comes to regulations, however, medical devices and the software that runs on them is subject to strict guidelines.  

Medical Device Regulations in General 

No universal system exists for regulating medical devices and software. Different countries and regions rely on different governing bodies and processes to approve such devices and software. However, it is useful to be aware of certain similarities in the processes if your device is subject to approval by different regulatory authorities. 

EU and USA classification 

The EU and the U.S. share almost identical classifications. Medical devices are categorized in three different classes based on safety risk and necessary regulatory control. The U.S. Food and Drug Administration (FDA) distinguishes Class I, Class II, and Class III medical devices. Class I devices generally pose the least risk to patients and/or users while Class III devices pose the highest risk. The EU uses a similar classification system. According to the European framework, there are four classes of medical devices: Class I, IIa, IIb and III – with Class III applying to the most risky devices. Despite similarities in the classification systems, the two regulatory bodies rely on different processes for approving devices. 

U.S. FDA 

In the United States, the FDA regulates all medical devices and software running on or connected to them. The process varies slightly depending on the class. Most Class I devices can be self-registered. Class II devices generally require a 510(k) submission for approval. For Class III devices, a Pre-Market (PMA) submission is also required. IronRooster has extensive experience in managing approval processes, lean more from our regulatory experts. 

EU Regulatory Framework 

In the EU, these regulations are part of the EU Regulatory Framework. Medical devices must undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device. Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.  

Asia 

Unlike the U.S. and the EU, Asia does not rely on a centralized system for regulating medical devices and software. As a result, each country has its own unique product registration requirements and classification systems. This makes transition from the U.S. or the EU to this region significantly more compleyx.

There you have it, a brief trip around the globe with medical device regulations. Hopefully we could help answer some of your questions, but if you would like to learn more, get in touch with us!