Medical device
CE marking

What is CE marking for medical devices, and why is it necessary?

CE marking is a mandatory conformity assessment mark required for medical devices (incl. in-vitro diagnostic devices) placed in the European market. The CE mark indicates that the medical device complies with the European Medical Device Regulation (EU MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR). CE marking also assures users, patients, and healthcare professionals that the device has undergone a conformity assessment process and meets the applicable safety protection requirements. After manufacturers successfully complete the conformity assessment, they can sign the EU Declaration of Conformity and affix the CE mark on the medical device.

Which medical devices need to have CE marking, and which do not?

All medical devices (incl. in-vitro diagnostic devices) sold in the European Economic Area (EEA), as well as in Switzerland, must be CE marked. The term “medical device” includes a wide range of products, from simple bandages and wheelchairs to more complex products such as prediction software, pacemakers and diagnostic equipment. In general, devices that have a higher potential risk to the patient require more rigorous conformity assessment. The classification of medical devices (incl. in-vitro diagnostic devices) is based on risk and determines the route of conformity assessment required and whether or not a Notified Body needs to be involved in the CE marking process. Note that similar devices may belong to different classes, depending on the intended purpose, the duration of use, or the anatomical position of the product.

What are the steps involved in obtaining CE marking for a medical device?

The steps involved in obtaining CE marking for a medical device vary depending on the risk classification of the device and the specific requirements of the applicable EU regulation. However, in general, the following are the key steps that the “legal manufacturer” (i.e. the entity responsible for CE-marking and liable for the medical device) needs to undertake:

• Identify the applicable EU legislation. For example, a product might be subject to the Medical Devices Regulation (EU MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR) or both, depending on their intended purpose and characteristics. And so-called “bordeline” products might fall under pharmaceutical, biocidal, or cosmetic legislation instead.
• Determine the classification of the device. This determines the conformity assessment route required, and the need for a Notified Body in the CE marking process.
• Establish and maintain a quality management system (QMS) that ensures process and product quality and must include key processes like risk management, clinical evaluation or post-market surveillance. Usually this follows the standard EN ISO 13485.
• Compile a technical documentation for the device that demonstrates compliance with the General Safety and Performance Requirements (GSPRs). This documentation, which includes all testing protocols and reports and clinical data, must be kept up-to-date and available for audit/inspection.
• Where required, apply for the certification by a Notified Body, which entails the inspection of the manufacturer’s QMS and technical documentation.
• Affix CE marking only once the conformity assessment is completed, i.e. when the Notified Body certificate is available (when needed) and the final EU Declaration of Conformity is issued.
• Post-market surveillance of the medical device to identify any issues or risks that arise during the device’s use, take appropriate actions, and report to the competent authorities any serious cases.