Team:Pasteur Paris/Law
REGULATIONS CONCERNING MEDICAL DEVICES
A new legal framework for medical devices ?
As the iGEM Pasteur Paris 2018 team is developing a new type of bionic prosthesis using a genetically modified biofilm, whose aim is to act as an interface between the human body and the machine, we were wondering how it would be regulated and which legal regime would be applied. We asked ourselves: is the current legislation sufficient to oversee the different aspects of the NeuronArch Project?
For the purpose of defining the legal status of our medical device, we decided to first examine the evolution of the legal regime and the legal definition, then analyze the different questions that can be raised and finally have a glimpse of the American system concerning medical device regulations.
The legal regime of medical devices in France
Medical devices have been regulated quite recently. Indeed, as drug regulations exist since 1965 and have been harmonized in Europe, medical devices were not regulated until 1990.
The philosophical ideas behind regulating drugs and medical devices are quite different. Indeed, the strategy of « the new approach » was applied to medical devices. It was based on a mutual recognition. Thus, member states of the EU were forced to admit on their territory, medical devices that were meeting the state of origin’s standards.
Since this system was considered as having a too weak control on medical devices, a revision was made in 2007 in order to partially correct these weaknesses. However, the « Breast implant scandal » made the legislator realize that the « new approach system » was insufficient to ensure the safety of EU citizens.
The European Parliament regulation (EU) 2017/745 and of the EU Council of 5th April 2017 was adopted and its 2 main goals were: ”ensure smooth functioning of the internal market as regards medical devices” and the setting of “high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products”.1
The definition of a medical device is very important, as it has to determine which procedures have to be followed and which laws it falls under. A medical device is defined as « any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means »2 . This definition is conceived as a reverse definition of drugs.
As “medical device” is a very broad group of products, a classification exists and permits the application of different procedures, depending on the class of the product (class I ; class IIa ; class IIb ; class III). This classification is based on their potential to cause harm.
The regulation (EU) 2017/745 has permitted some changes, for example, in the classification, which changed our device from a IIb class to a class III device. It has also set up a « Unique Device Identification System » and the « Eudamed » database, which is a key aspect of the regulation.
Questions raised by the NeuronArch project
According to Regulation 2017/745, medical devices “shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety“.
We raised questions about some aspects of the NeuronArch Project, such as responsibility, legal questions around the software that would be used together with our prosthesis, and the question of GMOs.
- Responsability : obligations of the manufacturer (article 10 of Regulation 2017/745), obligations of the importers (article 13 of Regulation 2017/745), obligations of the distributors (Article 14 of Regulation 2017/745), manufacturer’s obligations applied to importers, distributors or other persons (Article 16 of Regulation 2017/745).
- NeuronArch App : new obligations born from the statut of the software, depending on whether considered or not as a medical device.
- GMOs : can we launch a medical device inserting GMOs in human body ? The precautionary principle and the scientific uncertainty will certainly make it hard to pass all the clinical trial and get the marketing authorization. But nothing seems to clearly forbid its commercialization.
Glimpse of the American regime
In the USA, medical devices are regulated since the 70's, within the recommendations of the Cooper committee. However, the Medical Device Regulation Act was first introduced in May 1976.
In order to be launched on the market, medical devices need an authorization of the Food and Drug Administration (FDA).
The classification is a bit different from Europe. Indeed, there are 3 classes: class I, class II and class III with different procedures: premarket notification; premarket approval and product development protocol.
For class III products, there are 4 steps:
Once this procedure is fulfilled, the premarket authorization (PMA) is granted, and every modification of the product must be approved by the FDA.
Conclusion
Even though medical devices have been set aside for a long time, scientific advances are making them more and more complex with new questions raised. However, the law is, unfortunately, a field of study that is continuously chasing after new technologies. Indeed, the law often reacts specifically to new technologies and techniques. In the case of medical devices, the law is trying to build a broad framework in which all medical devices can fit. Unfortunately, some questions, as they are not specifically regulated, do not have fixed answers, or at least, not until the case is faced.
In the end, we cannot state whether the NeuronArch device will be able to enter the market, however, no laws seem to be against it.
REFERENCES
- Point (2), Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 april 2017
- Article 2, (1), Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 april 2017