Medical software and apps: CE-certification

The possibilities in the current digitalizing world seem limitless. These new possibilities also apply to medical devices, software, and apps. Digital applications vary from simple medical applications to software that is used in hospitals to monitor patient flows, such as the Ziekenhuisbedcheker. Examples of simple medical applications are the BreathBalanz app which helps users control their breathing or the Middin sex education app for obtaining specific information. Other examples of medical aiding applications are the Doula labor coach, JellinekMinnesota, the RIVM Tickbite awareness app, and the EFOX Parkinson’s exercises app. 

All medical software and applications are categorized under the heading; 'e-health'. The aim of e-health is to improve healthcare, which may concern the quality of healthcare and patient safety, but also the speed of a specific process in healthcare. E-health seems to be very effective in most cases, for this reason, it is rapidly gaining popularity. However, there are also some risks and consequences associated with the use of e-health. For example, 'Immature' technology or faults in the network connection can create obstacles. To limit these risks, good control is important. The control of medical devices is organized in Europe through a CE(‘’Conformité Européen) -certification. A CE-mark is mandatory for all medical devices within Europe.

What is CE-certification 

What is CE-certification? A CE-marking is a mark that indicates that medical devices, among other products, meet the European requirements in the field of safety, health, environmental, and consumer protection. For all medical devices in the European market, CE-certification can be used to check whether they meet the European requirements, which ensures transparency in the e-health market. A medical device containing a CE-marking is a strict requirement from the Health Care and Youth Inspectorate (IGJ), however many users and developers of e-health are not aware of this. What is CE-certification? A CE-certification is a mark, not to be confused with a quality mark. It only guarantees that a product meets the European requirements for safety, health, environmental, and consumer protection. This does not mean that a CE-certified device is by definition a high-quality device, but that it meets the European requirements and therefore is qualified as safe.

The regulations of ‘’Conformité Européen (CE) are described per product group/sector in various European directives and regulations. For medical devices, these are described in the Medical Device Regulation (MDR). For in-vitro diagnostic research, the Medical Devices Regulation for in-vitro diagnostics (IVDR) applies.

CE-certification and the associated guidelines are there to ensure that medical devices are safe. This means that the devices must not be harmful to your health, must function properly, and it should be clear how they should be used. If you as an organization implement or produce medical devices without a CE-marking, there are consequences. These consequences are imposed by the IGJ and range from an instruction or warning to a fine or order for the company to end their production of medical devices. 

Do I need a CE-certification for my app? 

To find out whether a tool or app needs a CE-mark, you can take the following steps. First, it must be determined in which risk classes the medical device or app is located. The MDR distinguishes risk classes I, IIa, IIb, and III. The IVDR makes a distinction in risk classes A, B, C, and D.

MDR:

IVDR:

After reviewing the above-mentioned schemes, there are three different follow-up steps possible: