Assistive technologies refers to technology used to provide necessary support to patients with restricted mobilities or injuries, and to assist them in conducting actions they would be unable to perform without assistance. To provide medical device manufacturers in maintaining compliance with applicable regulations, the Medicines & Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices market surveillance and regulation, issued guidance dedicated to the most important aspects related to assistive technologies and the way their application is governed by current legislation.
Assistive Technology: an Overview
It is important to mention that due to the specific nature of the topic, products intended to assist patients in performing certain functions that could be normally restricted due to the health issues could be defined either as a medical device or as an “aid for daily living”. The classification would depend on the way the manufacturer describes and markets the device. Thus, use of the device by healthcare professionals or in the sphere of public health protection itself does not directly constitute that the product should be deemed as a medical device subject to regulation under the appropriate framework. To be classified as a medical device, the product should be marketed as such a device, and the way it operates should be mechanical or physical.
At the same time, the positions regarding the regulatory approach to assistive technologies may differ substantially depending on the particular country even among the EU member states. These discrepancies in regulations could lead to situations when a device similar in the terms of design and composition but produced in different countries could be governed in various ways based on the current position of the respective national regulating authority. The agency also informs that it evaluates separately each particular application.
The guidance issued by the MHRA is based on the Medical Device Directive 93/42/EEC (MDD) that would be superseded by the Medical Device Regulations 2017/745 (MDR), so the authority notifies that certain changes would be made to the document in order to cover the specifics of the MDR.
Intended Purpose of a Medical Device
According to the general rule, the medical device has an intended medical purpose claimed by the manufacturer of the device and is indicated in the documentation supplied with the device, user guide or instruction for use, in labeling on the packaging and the device itself, and in promotional materials used for marketing purposes. At the same time, a device could have several intended purposes including both medical and non-medical ones. Thus, the product would be defined either as a medical device or as a product without an intended medical purpose and therefore exempted from the regulatory burden. In such a case, the classification of the product would depend on the primary intended purpose stated by its manufacturer.
One of the main criteria taken into account when assessing whether the product is a medical device or not is a connection with the patient it provides a corrective function to. In particular, this rule means that:
- The product that is directly intended to assist patients with disabilities is a medical device,
- The product that is intended to be used for a wide range of situations without a direct emphasis on the corrective function provided to the particular patient is not a medical device.
- If the manufacturer explicitly states that the product is intended to be used by patients with certain disabilities for the specified medical purpose, it is a medical device.
- If the product is intended to be used by a broad range of users even those having no disabilities, it is not a medical device.
In accordance with the risk-based classification, assistive technology medical devices are Class I devices or custom made devices. They could be produced either by the manufacturer as a separate legal entity or by the healthcare facility itself for internal use.
At the same time, there are a lot of products having design and functions similar to assistive medical devices, that however should not be classified as medical devices. Despite the fact that such products could be widely used by patients with certain disabilities or healthcare professionals in healthcare institutions, such products have no intended medical purpose, thus, according to the guidance, should be defined as “aids for daily living”. The authority also states that some of the products intended to be used by patients with disabilities still should not be classified as medical devices due to the functionality they provide. According to the example provided in the guidance, sticks used by the patients with visual impairment are intended to provide them with protection during walking and not to assist in it. Thus, such sticks should be classified as Personal Protective Equipment. At the same time, such products could be also subject to conformity assessment concerning safety and marked with the CE marks respectively.
Assistive Device Failure Reporting
The document also provides a recommendation to whom it may concern to notify the authority about any adverse events, side effects other than indicated by the manufacturers, or other issues arising when using the device. In particular, the MHRA advises patients to suspend using medical devices regarding which they have reasonable safety concerns and notify the appropriate healthcare professional or the manufacturer (or its authorized representative in the UK) indicated in labeling and documentation supplied with the device.
The authority reviews and analyses all adverse event reports to identify certain patterns in the manner they occur, paying special attention to ones associated with substantial harm to the patient’s health and similar consequences. The MHRA also sends all adverse event reports to the manufacturer for further investigation requiring them to provide the authority with the results of such investigation and then review the investigation report provided. In some cases, certain corrective and preventive actions could be reasonably necessary to be taken in order to reduce or prevent harm caused to the patients’ health. For example, the manufacturer could:
- Provide additional instructions necessary to use the device safely, or
- Make certain modifications to the device to eliminate the factors causing issues,
- Suspend the distribution of the devices of the particular type to the patients, or
- Announce the withdrawal of all devices of the particular type already supplied.
Summarising what is described above, the following criteria should be taken into consideration to define a product as a medical device:
- The intended purpose specified by the manufacturer and indicated in labeling, instruction for use, supplementary documentation and promotional materials;
- The corrective function provided by the product (e.g. special aid in mobility);
- The range of users the product is intended to (whether it is the general public or the patients with certain injuries, restricted mobility or disability).
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