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What is CE Marking and how can you obtain it?

What is CE Marking and how can you obtain it?

CE Marking is the number one indication that your medical device is safe on the market. It is established through a conformity assessment, which is based on the classification of the device. You can only place your device on the market with a CE Marking, that’s why we offer expert help in how to obtain it.

The CE mark is a logo that is placed on medical devices to prove that they meet the requirements of the specific regulations. This marking means that the product can be sold anywhere in the EU. Regulatory authorities can inspect CE marked devices, with new regulations, post market surveillance is becoming even more important. This is to increase the traceability of each product, which will increase the safety of each medical device.

To achieve a CE marking, you must declare that your medical device meets the requirements of the MDR (Medical Device Regulations – May 2020). This relates to the manufacturing process and whether or not your product needs to be sterilised. Following this, your device must be approved by a notified body. At Patient Guard, our consultants are qualified to act as ‘Qualified Persons’ in line with the MDR. Once the device has been approved, an identification number for a notified body must be placed below the CE marking.

There are some devices that do not require a CE marking. However they must adhere to the relevant regulations.

The consultants at Patient Guard are qualified to act as ‘Qualified Persons’, with over 40 years combined experience, our team can assist you with every aspect of achieving your CE marking.

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