What is CE marking?
CE marking is a certification mark that indicates a product’s compliance with European Union (EU) legislation. It is a legal requirement for many products, including medical devices, to be sold in the EU. And shows that the manufacturer has complied with the essential requirements for safety, health, and environmental protection.
Why is CE marking important?
It is important for several reasons. Firstly, it is a legal requirement for medical devices sold in the EU. Failure to comply with this requirement can result in legal action, including fines and product recalls. Secondly, it indicates that a medical device meets the minimum safety and performance requirements set out by the EU. This helps to protect patients, healthcare professionals, and the public from harm. Finally, it can improve the reputation of a manufacturer, as it shows that they are committed to producing safe and high-quality products.
How to obtain CE marking for medical devices?
To obtain CE marking for medical devices, manufacturers must follow a series of steps:
- Determine the appropriate classification for your device – Medical devices are classified according to the level of risk they pose to patients. The classification determines the level of assessment required and the conformity assessment route to follow.
- Conduct a conformity assessment – This involves evaluating your device to ensure that it meets the relevant safety and performance requirements. The assessment can be carried out by a notified body (a third-party organization designated by the EU) or by the manufacturer themselves, depending on the classification of the device.
- Prepare technical documentation – Manufacturers must prepare technical documentation that demonstrates compliance with the relevant EU legislation. This documentation must be available for inspection by regulatory authorities.
- Affix the CE mark – Once the device has been assessed and the technical documentation prepared, the manufacturer can affix the CE mark to the product and place it on the market.
MDR and IVDR Regulations
In addition, it is important to note that there are specific regulations that govern the medical device industry in the EU, such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). These regulations outline the requirements for the CE marking of medical devices.
CE marking is a legal requirement for medical devices sold in the EU. It indicates that a device meets the minimum safety and performance requirements set out by the EU. To obtain it manufacturers must follow a series of steps, including determining the appropriate classification for the device, conducting a conformity assessment, preparing technical documentation, and affixing the CE mark to the product. Compliance with the requirements helps to protect patients, healthcare professionals, and the public from harm, as well as improve the reputation of the manufacturer.