As the Coronavirus (COVID-19) outbreak evolve all over the world, safety and wellbeing is the topmost priority, so to safeguard people by managing the risk of infection within the operation; all we are counting to work for the safety and security, and wellbeing by following all necessary and required possible steps to put the safety of patients, our clients, and own people first.
Products that are classified as medical devices range from a band-aid to hearing aid i.e. from simple to complex in the market. Medical devices in the market need to be accountable to be safe for the consumer to satisfy the need of the user and patients.
CE Marking is the medical device manufacturer’s claim that products are safe for usage and have passed all the relevant European Medical Device Directives and are ready to be placed in the market. These Directives in the European Union (EU) outlines the safety and performance requirements for medical devices. In this context, the executive ensures that the products (Medical Devices) are made available for distribution or use (e.g. to a distributor, healthcare professional, or patient) for the first time or recently refurbished and whether it is provided with or without charge.
How to place CE Marking on the Medical Devices
Before placing a CE marking on a medical device, the device must follow the definition of Medical Devices and be accurately classified under the classification rules laid down in annex IX of the executive order on medical devices. The classifications of the Medical Devices are based on the risk associated with them. Class I (Im, Is), Class IIa, Class IIb, and Class III. Class I is associated with the lowest risk, while class III is associated with the highest risk medical devices.
CE Marking is also based on the class of these medical devices. The manufacturer of class I medical devices is self-responsible for the CE marking process. On the other hand, Class III manufacturers need to involve notified bodies in the certification of medical devices belonging to higher-risk classes.
Also, Check —>> CE Marking Certification in India
Who are notified bodies?
Notified bodies are authorized bodies to ensure that manufacturers have met all the required technical documentation and perform quality control for processes and products that may pose a significant risk.While CE marking the devices the manufacturer must involve the notified body for verifying its authenticity of the product, before marketing any medical devices, except class I devices. Class II and Class III involve sterile products or a measuring function, as well as in vitro diagnostic devices that are not covered by Annex II.
The technical documentation should be established based on safety and performance requirements. The purpose is to document the properties of the product to evaluate the quality, safety, and performance of the devices before getting placed on the market.
In addition, the documentation must comprise all clinical investigations and evaluations that are analyzed and assessed to document that the device complies with the essential requirements as to safety and performance. It also contains the risk analysis as the central point of the document to assess whether the risks associated with using the product are acceptable with the benefits for the individual user or patient.
Once the manufacturer has signed the EU declaration, the CE mark can be placed on the device. The CE marking should be placed visibly, legibly, and indelibly. The CE mark must also be affixed to the packaging of the device that ensures sterility of the device. The identification number for a notified body has to be placed below the CE mark.