{"id":2218522,"date":"2025-03-25T11:08:36","date_gmt":"2025-03-25T15:08:36","guid":{"rendered":"https:\/\/teguar.com\/eu\/?p=2218522"},"modified":"2025-10-29T15:16:55","modified_gmt":"2025-10-29T15:16:55","slug":"ce-certification-in-medical-devices","status":"publish","type":"post","link":"https:\/\/teguar.com\/eu\/en\/ce-certification-in-medical-devices\/","title":{"rendered":"CE Certification for Medical Devices in European Healthcare: Medical Computers Need Apply?"},"content":{"rendered":"\n

The digitalization of healthcare encompasses all areas of the hospital environment \u2014 from less hygienically sensitive areas such as patient administration, scheduling, and image diagnosis<\/a>, to interventional areas in intensive care units, ECUs, and operating theaters<\/a>.

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.<\/p>\n\n\n\n

\"Surgeons<\/figure>\n\n\n\n

Medical Devices vs Medical Computers<\/h2>\n\n\n\n

For several years, manufacturers of industrial computer products in Europe have been debating whether a medical all-in-one<\/a> (AIO) panel PC, medical tablet<\/a>, or medical-grade embedded PC<\/a> 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<\/a>. 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<\/em> of a medical device in accordance with article 2 paragraph (2) of EU MDR<\/a> 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.  <\/p>\n\n\n\n

Teguar\u2019s stance on this debate <\/h2>\n\n\n\n

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<\/a> 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.<\/p>\n\n\n\n

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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\u2019s 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.<\/p>\n<\/div>\n\n\n\n

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