CE marking is a European product marking; the letters CE is an abbreviation for Conformité Européenne (European Conformity). Products equipped with this marking can be sold in Europe without additional conditions.
This CE marking means that the product in question complies with the basic requirements for health, safety, function and environment, for example, and that the manufacturer or importer has complied with the prescribed control procedures. In practice, this means that the manufacturer is responsible for all injuries caused by the CE marked product. This is conditional on the user following the manufacturer's instructions.
For many products, the manufacturer is responsible for ensuring that these requirements are met. For certain products with high requirements for safety, a special control body must ensure that the requirements are complied with. CE marking demonstrates that a product has been developed in accordance with the European Directives.
We are very familiar with CE marking because only CE marked medical devices are permitted to be used in the health care services. A medical device is a product that is intended to be used for diagnosis, prevention, monitoring, or to treat or alleviate a disease or injury. Medical device accessories, such as a measuring instrument, are also covered by the regulations governing CE marking.
Medical device products include everything from sterile consumables to complicated high-technology equipment such as CTs. They also include medical treatment aids such as inhalers. But also software, such as Appar, that has been developed for medical purposes is classified as a medical device and must be CE marked. The same conditions apply to quality registers that cover a function for treatment at the individual level.
CE marking of software is a very important aspect of patient safety. The UCR Registry Center possesses the knowledge, processes and a quality system that can deal with CE marking of software and quality registers. UCR's IT technicians can develop tailored software and assume responsibility for ensuring it is CE marked. UCR can also assist with updating CE marking at each software upgrade.
Any problems with a medical device must be reported to the Medical Products Agency (MPA). The UCR Registry Center has routines for this reporting as well as routines for finding the causes of the problem, to remedy them, and to inform other users.
In their Guidelines for Manufacturers of medical devices in Class 1 the Medical Products Agency (MPA) describes the process that results in CE marking of a medical device.