Whenever you develop a product in the Health sector, it is important to determine whether it falls in the category of the Medical Devices or not. It is true that whenever products are considered to be medical devices, they are submitted to particular legislations that need to be followed and respected whenever you want to conceptualize or commercialize your product. Here is the definition of a Medical Device as interpreted by the European Legislation:
Definition of a Medical device
‘medical device’ means 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, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
Accessory for a Medical Device
Even if a product can be used as an annex to a medical device, the legal framework foresees certain measures that need to be respected. The definition for an accessory for a medical device goes as follows :
‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
In the Health Sector, the term “E-health” entails all products and services that make information and communication technologies intervene such as connected objects, applications, platforms to manage data… This means that a product that is developed in the health sector can be considered, depending on the case, as a medical device and if it is the case, it will need to respect the regulation in place for medical devices. The legal and the reimbursement context evolve so fast in the E-health domain, that it is important for entrepreneurs to be on top of such evolutions.
The lifetech.brussels’ experts can help you to determine in which category your product falls, can guide you through the steps you need to take to respect the legislation and can keep you up to date with regards to the latest developments.