CE Marking for Medical Device
A CE mark on medical devices gives the user confidence that the device has been manufactured with quality in mind.
CE marking for medical devices serves as proof of compliance with EU regulations. When medical equipment is CE marked, it can be freely marketed within the EU as long as they adhere to any applicable national regulations.
Why must medical equipment be CE marked?
A medical device’s CE marking for medical serves as proof that it complies with the relevant EU regulations. When medical equipment is CE marked, it can be sold freely in the EU as long as they adhere to any applicable national regulations (e.g. registration and language requirements).
According to the CE marking for medical device rule, all marketed medical equipment must have a CE label. Marketing here refers to the initial release of medical equipment for use or distribution (e.g. to a distributor, healthcare professional, or patient). This is true whether the equipment is brand-new or completely refurbished, whether it is provided for free or requires payment, and regardless of those factors.
However, equipment produced specifically for a patient, systems, procedure packs, and devices used in clinical research are exempt from the law’s requirement to bear the CE marking for medical devices.
How to get CE Marking for medical devices
A medical device must fit the criteria of a medical device and be correctly categorized following Annex VIII of the EU medical devices legislation to receive the CE certification. The four risk classes for medical devices are I, IIa, IIb, and III. Class III carries the most risk, whereas class I carries the lowest. For class I devices, the manufacturer completes the CE marking for medical devices procedure. A notifiable organization conducting the certification must complete CE Marking Certification for high-risk classes.
What notified bodies to do?
An organization known as a “notified body” has been permitted by the authorities to check that the producers of medical devices have the necessary technical documentation and quality control procedures in place for processes and goods that carry a high level of risk.
The notified body that manufacturers use for their medical devices is completely up to them.
Specialized technical writing
The general safety and performance standards outlined in Annex I of the medical devices regulation serve as the foundation for the technical documentation preparation. The objective is to record the product’s attributes based on an evaluation of the product’s performance, safety, and quality.
A medical evaluation must also be included in the documentation. To determine if the device complies with the general safety and performance requirements, clinical data, such as those from scientific journals and own clinical investigations, are analyzed and evaluated as part of a continuous clinical evaluation process. The goal of the medical inquiry is to prove that the risks of using the technology are tolerable when compared to the benefits that are anticipated.
The major piece of technical documentation is risk analysis. It highlights the risks connected to the device’s intended use. The purpose of the paper is to make it possible to determine if the dangers of using the technology are acceptable when compared to the advantages that users or patients stand to gain from doing so. In reaction to changes impacting the product’s risk profile, the risk analysis must be regularly updated (e.g. changes in production and experience from users).
Statement of compliance
The maker shall date, sign, and maintain a declaration of conformity to confirm that the product conforms with the requirements of the executive order upon satisfaction of the safety and performance standards and completion of the technical documentation.
CE Marking for medical devices
The CE marking for medical devices can be applied to the goods after the producer has acknowledged the EU declaration of conformity. The CE marking for medical devices itself must be visible, legible, and indelible and must be affixed to the instructions for use to signify that the product meets the requirements of the law.
The product itself and its container must both have the CE designation. The CE marking for medical devices is applied to the packaging that keeps the product sterile in the case of sterile equipment. For devices involving notified bodies, the CE marking must be accompanied by the notified body’s identification number, which was used to aid in the product’s evaluation.