Technical Articles & Industry Trends
CE Certification for Medical Devices in European Healthcare: Medical Computers Need Apply?
The digitalization of healthcare encompasses all areas of the hospital environment — from less hygienically sensitive areas such as patient administration, scheduling, and image diagnosis, to interventional areas in intensive care units, ECUs, and operating theaters.
The world of IT systems, too, has entered this environment; and all involved are faced with its complex challenges, namely healthcare IT staff and biomedical engineers. A level of uncertainty arises with the selection criteria for suitable IT systems, considering their safety for patients and hospital staff, their overall usability, and potential risk while in use.
Medical Devices vs Medical Computers
For several years, manufacturers of industrial computer products in Europe have been debating whether a medical all-in-one (AIO) panel PC, medical tablet, or medical-grade embedded PC used in a hospital operating room can, should, or must be considered a medical device. A PC merely labeled as a medical device without application software and connected accessories for medical purposes cannot be used to monitor, diagnose, or cure a patient in such a configuration, and therefore does not meet the criteria of a medical device according to article 2 paragraph (1) of EU MDR 2017/745. When should a medical computer become a medical device? Is it reasonable to declare such a device as a medical device?
It is conceivable to consider the computer system as an accessory of a medical device in accordance with article 2 paragraph (2) of EU MDR 2017/745. However, this presupposes that the manufacturer of such a medical AIO panel PC, embedded PC, or tablet PC can precisely define its intended purpose with regard to a specific medical target product and carry out the necessary risk assessment, usability testing, and clinical evaluation. However, as the manufacturer of the computer system usually does not have fundamental knowledge and experience in this area, this approach is not feasible.
Teguar’s stance on this debate
At Teguar we have decided to design products suitable for becoming a building block of a medical system. The products we offer are not standalone medical devices, but might become an essential part of one. Though a bit of an exaggeration, in this way, compare Teguar's products to a handful of M6 stainless steel screws, which can become a necessary and important part of a complex medical system, and on whose quality and reliability the functionality of the overall system depends, but which does not perform the primary medical function itself. We see it as our task to develop and manufacture our AIO panel computers, embedded computers, tablet PCs, and displays with foresight to their subsequent use in mission-critical environments, to a high standard of quality in order to meet a wide berth of challenging requirements, such as their possible use in medical systems.
However, at the time of quality approval for our products, one cannot predict how they may be used in every specific medical environment or system. For this reason, the intended use of Teguar’s medical PCs and displays cannot be defined beyond the input and output of data, its processing, display, and storage. A risk assessment of relevant possible malfunctions cannot be carried out. This can only be done at the time when a medical device is formed from various hardware and software components, at which point the effect of the type and frequency of malfunctions on the essential performance can be evaluated and verified.
Nevertheless, Teguar is aware of its responsibility as a supplier of systems for sensitive medical areas. In addition to the required conformity for IT products and the applicable harmonized standards, systems intended for later use in these areas are subjected to additional tests as prescribed for medical devices. These include stricter limit values for electromagnetic compatibility, leakage currents, and protective measures for user and patient protection (MOP: Means of Protection), as well as the effects of strong electromagnetic fields on the functionality of the devices. The systems are hygienically designed from materials withstanding frequent cleaning and disinfection. Often Teguar provides test reporting that customers can use to ensure our portion of their final system will function within the standard they need the complete system to comply with.
Which legal framework was chosen by Teguar for CE conformity?
The European Union (EU) has established several directives and regulations that govern the safety, performance, and environmental impact of electrical and electronic equipment, including computers, tablet computers, and displays. Key directives relevant in this context include the General Product Safety Regulation (GPSR), Low Voltage Directive (LVD), the Electromagnetic Compatibility Directive (EMC), and the Medical Device Regulation (MDR).
Economic operators in the EU, who are responsible for placing the product on the EU market, are legally required to declare conformity of their manufactured or imported goods with the relevant directive(s) and must ensure this declaration can be verified by the corresponding harmonized standards applied.
The following example of our upcoming release, the TM-7200 Clarion Medical AIO, shows conformity and applicable standards as follows. The TM-7200 is powered by an external medical grade power supply and equipped with a backup battery, Wi-Fi/Bluetooth, and RFID modules.
EU conformity with the following regulations and directives (external power supply is not considered here):
- General Product Safety Directive (GPSD), 2023/988/EU
- Electromagnetic Compatibility (EMC) Directive, 2014/30/EU
- Radio Equipment Directive (RED), 2014/53/EU
- Battery Directive, 2006/66/EC
- RoHS Directive, 2011/65/EU
- REACH Regulation, EC 1907/2006
Each regulation and directive is confirmed by successful compliance with a series of harmonized standards such as EN 62368-1, EN 55032, EN 61000-3-2 and EN 61000-3-3 and others. Additionally, though not belonging to the regulations and directives above, we also ensure compliance with parts of the EN 60601-1 and EN 60601-1-2 standards. Compliance with certain parts of the latter two standards makes it easier for medical device manufacturers and system integrators to obtain approval for their medical devices.
Conclusion
If you are a medical device manufacturer looking to bring a medical device to the market and you need a high performance, elegant AIO panel computer, embedded computer, tablet PC, or display to be part of your system, let’s talk. Teguar can provide a base for you to build your medical device around and can contain your risk by showing compliance to applicable standards that will be part of your journey towards bringing your medical innovations to reality.
