With the increasingly rapid development of technology, bionic innovations in the healthcare sector open headlines in the news on a regular basis. A bionic hand connected to the nervous system that allows amputees to “feel” again, implanted electrodes that translate thought into actions or movements, enabling a paraplegic person to walk again, or a bionic eye that enables blind people to see again. These are some of the fascinating examples that we come across nowadays, but is the law prepared to adequately regulate these innovative devices or is it lagging behind?
“Bionics” and “bionic devices” are not part of the legal vocabulary and are not considered as such under the European Union’s life sciences laws. According to the Cambridge Dictionary, bionics is “the science of creating artificial systems or devices that can work as parts of living organisms”. Despite being related, bionic devices differ from simple prosthetic devices, inasmuch as these need the body’s power to move or simply replace a body part that is missing, whereas bionic limbs will use electrical signals from an individual’s body to work, providing more added value than solely mechanically replacing what has been lost.
Many of these devices will fall under the category of medical devices, regulated by the recent Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MD Regulation), which applies since 26 May 2021. Under the MD Regulation, medical devices can be defined as “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, (…) or compensation for, an injury or disability, (…) investigation, replacement or modification of the anatomy or of a physiological or pathological process or state”.
It is easy to understand that the above-mentioned definition is extremely broad, ranging from compression socks and mouthwash to insulin pens and cardiac pacemakers. Adding to this, bionic devices themselves will also be very different from each other, with different levels of invasiveness and complexity. They will therefore also fall within different subcategories of medical devices – some are implantable devices, such as a cochlear implant, others are neural prostheses that replace missing limbs and are controlled by users’ signals. They will in principle always be personalised medical devices, which may have consequences on the rules applicable to them. More specifically, they will possibly fall under the category of “custom-made medical devices”, which are defined under the MD Regulation as “any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs”.
However, the rules applicable to bionic devices will not necessarily take into account the differences between these types of devices and other medical devices. It has already been argued that the existing medical devices legislation is overly general, not taking particular notice of the specificities of prostheses, for example. If that is the case for common prostheses, what can be said of bionic prostheses, which present additional complexities?
In fact, when discussing bionic devices, there are many issues to consider. For example, these devices may face threats of hacking attempts, as they will be controlled by software and will probably be connected to the Internet. The requirements on security and safety for these types of devices will differ from those applicable to simpler medical devices. In any case, the MD Regulation already pays particular attention to cybersecurity issues and specific guidance has been issued by the Medical Device Coordination Group, as more medical devices consist of software or incorporate electronically programmable systems, and are thus prone to face this type of risks.
Another issue that has been pointed out is the right to repair of these devices. In this extremely innovative sector, what is considered state-of-the-art changes rapidly and the devices may easily become obsolete, the company may decide to discontinue the device or even go bankrupt. Users may face the lack of suitable replacement parts or expertise to repair their devices, rendering their devices unusable. This is precisely what happened with the Argus retinal implant. Are current consumer or medical devices laws prepared to deal with the events that may occur during the entire life cycle of these products?
The use of artificial intelligence in the development of medical devices is increasing and the evolution of bionics involving artificial intelligence has an incredible potential to “catapult research in the field to new heights”. This may, however, bring an additional set of challenges of its own for which the law is not yet prepared. One of them is the compatibility between the forthcoming EU Artificial Intelligence Act and the existing MD Regulation.
Apart from a scarce regulatory landscape that may be applicable in some cases, bionic solutions may also face other types of obstacles related, for instance, to their placing on the market. These devices are mainly directed at very small cohorts of patients and are extremely expensive. They also undergo, in general, long periods of research and take a long time to be certified by notified bodies. All these factors hinder finding funding for their development. In fact, great discoveries may never be placed on the market to be sold to people needing them because they were not attractive enough for investors. Orphan medicines face similar challenges. According to the European Medicines Agency, these are medicines whose aim is to prevent, diagnose or treat “a life-threatening or chronically debilitating condition that is rare or where the medicine is unlikely to generate sufficient profit to justify research and development costs”. As it is essential that there are pharma companies specialised in developing orphan drugs, it is also crucial to ensure that the research and development of bionic medical devices is supported to reach patients that need these discoveries, and does not remain forever in the lab.
In summary, the rapid advancement of bionic technology holds immense promise for healthcare, yet the legal framework lags. As technology and law intersect, new challenges related to security, right to repair, and harmonizing regulations with AI-driven progress may emerge. Long processes for research and market entry also hinder accessibility. In the end, to unleash the full potential of these devices, the law still needs to be adapted to take into account the specificities of this new bionic world.
