MDR for the concept of medical devices are becoming increasingly rigorous! It is important to know whether a product is a medical device, because this will determine whether the MDR applies to the product. Therefore, it has a significant impact on how the device is implemented and how the product is approved for the European market. The easiest way to describe what a medical device is is that a medical device is something found in a hospital for treatment, not a drug. However, things are not that simple. Medical devices are everywhere, not just in hospitals; they can be bought in pharmacies or supermarkets like Band-Aids. So how to distinguish it, let’s discuss together!
01. Specific details!
In the MDR, Article 2 “Definitions” provides for medical devices, as the first definition, where medical devices include specific medical purposes such as diagnosis, monitoring, treatment, relief and other purposes. An important aspect of deciding whether a product is a medical device is that it is intended to treat or monitor a patient, rather than a “drug”.
Treatment can be carried out in different ways, the full definition of which can be found in Article 2 of the Medical Device Regulation. So not only is it a tangible product that can be touched, but it may also be a medical device; a stand-alone software or mobile application can also be used.
Medical device intended purpose is a very important original English expression that you should pay attention to. In order to determine whether a product is a medical device, the intended purpose or intended use needs to be known. This intended purpose is the intended use of the product as claimed by the legitimate manufacturer of the product. Therefore, if a manufacturer plans to sell a product to the EU that meets the definition of a medical device, that product should also be regulated and treated as a medical device.
For example, if the product is a watch with built-in oxygen saturation measurement, but it is intended only for fitness, it would not be classified as a medical device because it is not intended for diagnosis or treatment.
However, if it is used to monitor a person’s oxygen saturation for medical or therapeutic purposes, it becomes a medical device.
MDR is definedintended purpose in this way, ‘based on the data provided by the manufacturer in the labeling, instructions for use, promotional or sales materials or statements and the intended use of the device as specified by the manufacturer in the clinical evaluation. MDR, Article 2, 12
Clinical evaluation is the core concept of MDR. It is the process by which the manufacturer evaluates relevant clinical data to ensure that the medical device is operating within its intended purpose and is safe and effective. The results of the clinical evaluation are documented in a clinical evaluation report.
It is critical to distinguish between clinical evaluations and clinical investigations, which are conducted on human subjects.
The intended use should not be merely a statement in the instructions for use; it also needs to be exactly as stated by the manufacturer on the label, in promotional or marketing materials, or other statements made by the company.
It is therefore of utmost importance that the manufacturer strictly defines the intended use of the device both before and after it is placed on the market.
02. How to determine whether a product is a medical device?
Usually, deciding whether a product should be a medical device is fairly easy. Sometimes, however, it is not so obvious. If it is not obvious, it is highly recommended to read the exact MDR definition verbatim and to check the classification annex at the end of the MDR, in this case Annex 8. This annex provides insight on how to use the medical device.
There are also guidance documents that can be used, such as the Borderline manual introduced under MDD. It does not apply exactly to the MDR, but the principles in the Borderline document can be used and extrapolated to what is in the MDR.
Usually, deciding whether a product should be a medical device is fairly easy. Sometimes, however, it is not so obvious. If it is not obvious, it is highly recommended to read the exact MDR definition verbatim and to check the classification annex at the end of the MDR, in this case Annex 8. This annex provides insight on how to use the medical device.
There are also guidance documents that can be used, such as the Borderline manual introduced under MDD. It does not apply exactly to the MDR, but the principles in the Borderline document can be used and extrapolated to what is in the MDR.
Some products are clearly medical devices in their own right, but are difficult to define as products used with medical devices. They are called accessories, and they are also regulated as medical devices, so the same requirements apply.
It is sometimes difficult to determine what is a medical device and what is an accessory, and there are different views on this, but since the requirements are the same for both, it doesn’t matter as much. In the worst case scenario, the manufacturer and the NB agency will discuss what is a medical device and what is an accessory.
Taking the intravenous drip chamber as an example, there is a roller clamp used with the intravenous drip chamber on the drip line. So, the two medical devices can be used in combination or alone. But before it can work in the IV drip room, it needs to be hung on a bracket so that the IV drip can actually reach the patient.
This bracket is necessary for the intended use of the drip chamber and is therefore an accessory to this medical device. Accessories required to fulfill the intended use of a medical device are also medical devices. But the tricky part is the question – is the roller clamp an accessory?
The answer is likely no, since it is commonly used in IV drips and potentially other medical device applications, it is a combination. On the other hand, the brace likely has no other medical use, so it should probably be considered an accessory.
A number of other products should also be considered medical devices, such as devices to control or support conception. Products specifically designed to clean, disinfect or sterilize medical devices are themselves regulated as medical devices. There is a special group of products that are not medical devices by definition, meaning they do not fall under the MDR definition of a medical device, but the MDR still applies to them.
These products may be implanted, invasive or harmful, and are usually used only for everyday purposes, or at least not for medical purposes. These were not previously specified in the MDD, but they must now meet the same requirements as medical devices. Such products listed in Annex XVI without a medical purpose include: colored contact lenses, surgically invasive products without a medical purpose (excluding piercings and tattoos), dermal fillers, liposuction devices, and devices that use light, infrared light or lasers to remove hair and tattoos.
Finally, an interesting thing to mention is that prevention of injury or disability is not included in the definition of medical devices, as this would make the device a personal protective equipment (PPE), and there is another directive for such devices.
Please note that this is all for the purpose of the EU definition of a medical device. Other definitions of medical devices may exist in other markets around the world, meaning that a product that is considered a medical device in the US may not be considered a medical device in the EU. It is not the country of the manufacturer that defines what is a medical device, but the legislation of the country where the product is sold. It is worth noting that the MDR has replaced the previous Medical Device Directive MDD and AIMDD.
AIMDD was the directive for active implantable medical devices, so it is now included in the MDR, meaning that there is now only one regulation for all medical devices in Europe.
Obviously, under the MDR, the manufacturer (and sometimes the legal manufacturer) is the person responsible for the medical device. This is the natural or legal person who is responsible for the medical device before and after it is placed on the market by marking the device with its name or trademark. The manufacturer does not necessarily manufacture the product, which is a crucial concept since many medical devices are produced by subcontractors.
But in any case, it is the manufacturer who is responsible for the device, and this is the operator to be identified on the medical device label. This is so that regulatory authorities can determine which organization is ultimately responsible for the medical devices on the market. Who is the legitimate manufacturer must be very clear on the label.
This should be written primarily on the device itself, but if that is not possible, at least on the label, packaging materials and accompanying documentation. If the device is only labeled with a trademark, the actual name of the legitimate manufacturer also needs to be stated. In short, learning and ultimately deciding what is a medical device is not always easy, but following the MDR carefully does not allow for mistakes.
