BLOG: Device classification - The first step of your regulatory strategy

by Francesca Davis on 5 Jul 2024

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If you are developing a device, you may find yourself wondering, how do I know if it is a medical device? If you are unsure, use the RegMetrics software and see if your equipment fulfills the medical device criteria. From there, you can also use RegMetrics to help with the regulatory strategy in a more simple manner.

Medical Device Regulation (MDR) is the European law which every medical device needs to adhere to, to ensure that it is safe and effective for humans to use. In Vitro Diagnostics devices (IVDR) have to go through this similar regulation, as these also need to be regulated for safety and performance. It is vital that all medical devices do not pose a risk before they are rolled out for worldwide use. You can find more information about IVDR classification here.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) are responsible for the medical devices regulation in the UK. Their role is to protect and improve public health, and support innovation through scientific research and development. They make sure that all medical devices adhere to the regulations so that they are safe to use and do what it is meant to do.

An important stage in the regulation strategy is classifying your device to determine how much of a risk it may be to those who will use it. When talking about classification for medical devices, it means that your device will be placed in one of four categories as described in the MDR. These are class I, class IIa, class IIb and class III.

If your medical device is considered to be class I, this means that your equipment is relatively low risk. An example of a medical device that would be classified as class I is a bandage, as this will cause minimum risk to a patient.

A class III medical device is a much higher risk for a patient. Medical equipment such as pacemakers are classified as class III because they are placed within the human body, therefore lots of factors need to be considered to make sure that it is safe and all potential risk to the patient has to have been mitigated. The risk of a class III medical device means that more trials and procedures will be carried out to ensure its safety, and this often means that developing class III devices is also significantly more expensive than developing medical devices that don't require extensive testing.

MDR classification can seem daunting and confusing, but most of all it can feel like a very long process. RegMetrics makes medical device regulation simple, accessible, time saving and cost effective. You can use RegMetrics to classify your medical device and to make your medical device regulation strategy easy and hassle free.