On the 14th of November, we celebrate World Diabetes Day, commemorating the birthday of Frederick Banting, co-discoverer of insulin. Millions of people with diabetes face daily challenges. Controlling blood sugar daily requires being resilient, organized, and responsible, which impacts both the physical and mental well-being of people who have diabetes. It is incredibly demanding for children and their parents and requires daily cooperation. Fortunately, modern medicine offers many facilities that make diabetic life more accessible and of better quality. Let’s check out the different types of diabetes medical devices and how they might help patients.
Be smart – technology achievements in having diabetes under control
To make diabetic life simpler, there are some options in the area of blood glucose monitoring and insulin administration. Recently, continuous glucose monitors have become increasingly popular- tiny sensors inserted just below the skin, usually on the belly or arm. The sensor provides real-time daily updates and alerts the patient when glucose levels become too high or too low. It works through an electrode that measures glucose levels within the tissue fluid rather than directly from the blood. It connects with, e.g., a smartphone, so the diabetic may easily analyze blood glucose trends.
Another innovative device is the smart insulin pen, which is an upgraded version of the standard insulin pen. It allows users to dial in the correct dose of insulin and calculate the dose based on their blood glucose level and carbohydrate intake.
Other devices, nowadays widely in use are:
- blood glucose meter – small, portable device with a screen that comes with test strips that are designed to use with the meter, considered to be one of the most standard diabetes devices. It requires to prick the finger with a lancet device, apply a small drop of blood to the test strip, and the blood glucose level is displayed on the screen within seconds.
- insulin pump – an external device that is attached to the body, it mimics the insulin release by the pancreas similar to someone without diabetes. It can be programmed to release insulin continuously throughout the day or as surge release.
A really innovative option is the combination of continuous glucose monitors with insulin pumps. This provides continuous glucose checks with the pump’s automatic insulin delivery. Scientists are also working on some new ideas, like implantable devices that contain encapsulated cells that produce insulin, which might help people with diabetes type I.
As the number of diabetes mobile applications has been growing rapidly, it is increasingly possible that health information exchange between health systems (e.g., electronic health records), mobile applications, and sensors will become a standard, and the health care of diabetics will be adjusted on a daily basis.
It is superb that an increasing number of technology options are available for diabetics, but many people might ask about the reliability of these devices. Are they tested before launch on the market? The answer is yes! They have to be properly checked before they are approved for use. Let’s have a look at the requirements.
Be scrupulous – classify medical device appropriately
In Europe, medical devices have to meet requirements that are mainly presented in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (known as MDR, Medical Device Regulation) and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. All devices must comply with all relevant obligations, e.g., meet the general safety and performance requirements and be CE marked (except custom-made devices and devices intended for clinical investigation). Requirements depend on the class for which the medical device is classified to. According to MDR Article 51, devices are divided into the following classes: I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. In addition, and according to Article 52(7)(a),(b) and (c), Class I devices can be further subdivided into Is – sterile condition, Im – measuring function and Ir – reusable surgical. Simply put, the higher the class, the more restrictive the requirements. A premarket clinical investigation is usually compulsory for implantable and class III devices, although some exceptions are possible.
How the medical devices mentioned in the previous paragraph should be classified? At first glance, we could classify them as class IIb or maybe III or … IIa. As can be seen, it is not so easy to decide. In making the right decision, 22 rules outlined in MDR, Annex VIII, are of help. Still, the proper classification might be complicated if we realize that the part of the device is not only the physical appliance but also the digital software and hardware technology that enable the usage, which may additionally be related to Artificial Intelligence (AI). They should also be assessed by taking MDR and AI ACT into account. Are you feeling dizzy about the classes? Let’s complicate it even more! In vitro diagnostic medical devices (IVD), like blood glucose meter, are classified into another four risk classes ranging from low to high risk: Class A, B, C, and D. Risk of using the IVD encompasses both the risk to individual patients and the risk to public health.
Classes determine the activities before placing the device on the market and post-introduction actions. Like medicinal products, medical devices are also under post-market surveillance. Depending on the class, the manufacturer must prepare special reports that are presented to competent authorities on request (class I) or updated at least annually (class IIb, III, C, and D) or at least every 2 years (class IIa).
Even if the latest regulatory shifts seem challenging, they pave the way for a more secure, ingenious, and patient-centric future for medical devices in diabetes.
Summary
Are you inspired to develop an innovative medical device to make diabetic life easier but afraid of regulations? Let us help you. Our experts can conduct all assessment and notification procedures required by Regulations (EU) 2017/745 and 2017/746.
Even if some devices are still covered by the transitional period, even until 2029, do not hesitate to adapt your medical devices to new requirements right now.
We encourage you to read the blog post A History of Pharmacovigilance, which inspired this article.