What are Ce Marking and Who Marks Them?

CE marking is one of the most important criteria that a health equipment manufacturer has to follow. The following article gives an overview of the entire CE marking procedure for medical device independent applications. All medical equipment, software or hardware, put into the European market has to bear a CE mark as an indication that it complies with certain quality standards. This ensures the end user that the device they are using has been designed according to high quality standards and that it will offer reliable service.

Medical device manufacturers do not have to abide by the strict guidelines of the CE marking process for independent applications. There is actually no legal obligation for these manufacturers to ensure that their products are compliant with the highest possible quality standards. They are also not obligated to offer consumers any kind of guarantee concerning the conformity of their products to the highest possible industry specifications. Manufacturers are only required to comply with the basic guidelines that have been approved by the European Union.

A major part of this requirement is the compulsory conformity assessment carried out by the European Union's conformity assessment body, ECDI. Through web workshops conducted by the regulatory body, manufacturers can make sure that their products conform to the highest possible standards, as well as obtain an affirmation that the product meets the legal requirements of member states. The majority of manufacturers take advantage of this aspect and arrange for web workshops for their customers. The CE marking medical devices that these companies offer through their workshops are designed to meet the overall requirements of each country's conformity assessment body.

The second aspect that the CE marking process of medical devices involves is the re-certification of devices that have already been approved. Once a product has been approved, it cannot be re-approved for another twenty-four months. The re-certification of medical devices is done via the European Monitoring Network, EUROST. This is done in order to ensure that all the components of the device conform to the CE marking regulations of each and every country. By using a re-certification, a device that has been approved previously will be given a new certification, which will guarantee that the product meets all the CE marking regulations for sale.

The third aspect that is included in the whole CE marking process of medical devices is the compulsory comparison of technical files between different medical devices. Every product that you see or buy must undergo a comparison between it and another similar product from the market. If this comparison is not made, the benefits of buying the product will be reduced significantly. For instance, by making a comparison between identical IVDs, a lot of people would have the wrong impression that identical quality is being offered by them. This leads to a lot of purchases on inferior devices.

Moreover, the procedure for re-licensing devices that are already sold also involves certain technical documentation. It is part of the obligations that come with the purchase of a medical device. Once these two processes have been completed, all that remains is the next step in the conformity assessment - a labeling of the medical device. There are a number of requirements that will be applied to identify the components that make up the devices. One of the most important criteria is the list of ingredients that are contained in the device, together with the list of substances and/or compounds that have not been found in the technical documentation of any other similar devices from the same category.

With the help of the Europe Payment Platform (EPC), manufacturers who take part in the conformity assessment can get a certificate that will indicate to consumers that the medical devices they are selling are legitimate products. Most often, this certification is provided within three to four months. This means that the manufacturer or supplier can easily change any misidentifying or false data into an item that conforms to the necessary guidelines.

The second part of the conformity assessment process deals with the proof of proper functioning. The CE marking of medical devices is applied on the product with the help of a set of quality standards, which indicate how the device should function in relation to the guidelines set forth by the European Union. While many companies are comfortable with the use of the standard set forth by the EU, manufacturers of electrical and electronic products should also have their products checked to ensure that they comply with the CE marking regime. To ease the application of the CE marking program, several electronic companies offer their own suite of standalone software that will do the necessary checks automatically. Most of these standalone software applications are available on the market for a price that is significantly lower than what one would have to pay for the services of a compliance officer.