As part of trading within the European Economic Area, you will often see products such as toys, electrical equipment and medical devices carry the CE mark, or Conformité Européen mark, meaning European conformity.
This CE mark exists to show that a manufacturer has met the applicable legal requirements for a certain product to be considered safe on the EU market. With the new Medical Device Regulation (MDR), manufacturers have to ensure that they comply with new changes. This is true even if the product was manufactured outside the EEA.
CE marking of medical devices
A medical device is a product or a device that is intended for medical use. Examples of medical devices include hearing aids, condoms, plasters and software. The CE marking proves that the manufacturer has ensured that a medical device meets the EU health-, safety- and environmental standards.
The CE mark is also an indicator of a product’s compliance with EU legislations. Medical devices sold on the single market must have the CE marking, either on the product itself or on the instructions for use.
With the newly released Medical Device Regulation (MDR), manufacturers are required to ensure that existing products on the market comply with the regulation to carry the CE mark. For you as a medical device user, the CE mark tells you that both new medical devices and medical devices released prior to the new regulation conform with the necessary requirements for a safe medical device.
Does the CE mark mean that the medical device has a formal approval?
In some cases, having a CE mark on a medical device means that it does have formal approval by an external party. In the EU, these external parties or organisations are referred to as notified bodies.
However, not all CE-marked medical devices have been reviewed or approved by a notified body. This depends on the classification of the medical device. The classification is done based on the risk profile, and the different risk classes are defined in the medical device regulation.
For example, class I medical devices are considered the least harmful, and they do not require review or audit by an external party. However, all medical devices are required to carry the CE-mark, which is a self-certification by the manufacturer of the medical device.
For sterile class I devices or class I medical devices with measuring function, a notified body has to be involved.
For higher classes of medical devices, that is class II and III, a notified body must review or approve the medical device. This includes reviewing the technical documentation of the medical device and auditing the medical device manufacturer to ensure that it has followed the required standards and regulations for a safe medical device before it is released to the market.
Medical devices missing the CE mark
Sometimes you may find products that appear to be medical devices that lack the CE mark. If you only look at the physical product and it is really small, like a tooth implant, then it may be just because of that. If there is no room on the device, the CE mark can be found on the packaging and instructions for use instead of on the product itself. Look there instead to see if you find the CE mark.
Products with medical device features
Yet another reason for why you may not be able to find the CE mark on a product is because the manufacturer has left it out, either on purpose or by accident. Even though the product may technically be a medical device, the manufacturer has not done what is required in this area. This is particularly common with low risk products, because some manufacturers of such products do not know that it is a medical device or don’t care. And the regulatory bodies don’t spend enough resources on market surveillance. They tend to focus on higher risk products. So, if you find a product that you think should be a medical device and you don’t find the CE mark on it, you should avoid it or be very careful with it. You may even consider sending a notice to the competent authorities about it.
Some products could be used as medical devices based on the features they have, for example an activity bracelet with a built-in heart rate monitor. However, if the manufacturer does not specify a medical indication, but on the contrary states that it is not for medical use, it does not need to have the CE mark. This also means that you shouldn’t use the device for any other purpose than the manufacturer states.
For you as a user, the CE mark shows that a product or medical device on the EU market conforms to necessary requirements and standards relating to performance, quality and most importantly safety.
If a product that you believe is a medical device is missing the CE mark, you should be very careful. You should also keep your eyes open for fake CE marks when purchasing medical devices.
This post has been sponsored by Gantus AB
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