CE MARKING OF MEDICAL DEVICES

Medical Device and Software Definition

A medical device includes, objects, materials, medical software and apps used for therapeutic or diagnostic purposes such as:

• Detecting, preventing, monitoring, treating or alleviating disease;
• Monitoring or compensating for injuries or disabilities;
• Examination, replacing or modifying anatomical structures or physiological processes;
• Regulating fertility.

Intended use

The manufacturer defines the intended use of the medical software, specifying its purpose (e.g., diagnosis, treatment, or monitoring) and the target user groups.

Medical devices, including software and apps, are classified into four risk categories (I, IIa, IIb, III) based on the level of risk. Additional subclasses include Is (sterile Class I devices), Im (Class I devices with a measuring function), and Ir (reusable Class I surgical instruments). The classification follows rules outlined in Annex IX of the Medical Devices Regulation (EU) 2017/745.

Medical software that controls a device or influences its use is automatically assigned to the same class as the device. If the software is independent of another product or accessory, it is classified independently.

Manufacturers choose a conformity assessment procedure based on the device's classification. For most devices (except Class I), a notified body like TÜV must be involved.

One of the most used conformity assessment procedures is the one according to Annex IX of the MDR, which requires the manufacturer to have a complete quality assurance system in place. SINOVO holds an EC certificate for a complete quality management system in accordance with the MDR and is therefore authorised to act as a distributor for your medical software.

The components of a conformity assessment procedure include:

• Ensuring the software or app meets the essential requirements, such as acceptable risk-benefit ratios and safety.
• Conducting risk management to identify existing risks..
• Preparing technical documentation, which is required for all classes of medical devices and proves compliance with European regulations.
• Implementing a quality management system (DIN EN ISO 13485) if SINOVO is not the distributor.
• Appointing a safety officer and training consultants for medical devices.
• Setting up a monitoring and reporting system
• Registering the software with the Global Medical Devices Nomenclature (GMDN) at the Federal Institute for Drugs and Medical Devices (BfArM).
• Preparing a written declaration of conformity, confirming compliance with the essential requirements.
• Conducting a clinical evaluation or study, where required.

Once all steps are completed, the CE mark can be applied to the product.

As soon as the conformity assessment procedure and the technical documentation have been successfully completed, the manufacturer or its representative issues the market release. The manufacturer or his representative places the medical software / medical app on the market with CE marking.

In the case of medical software that is placed on the market "standalone" the CE mark should be placed in one of the following locations if possible:

• Start or splash screen
• “About” or “Help” section
• On the Website
• Accompanying materials, i.e. in particular instructions for use or manuals

There is no regulatory obligation to affix the CE mark in a web or app store.

After the software is labeled with the CE mark, manufacturers must provide relevant documentation to national authorities upon request.