The term “medical devices” covers all products used for the diagnosis, prevention, monitoring, treatment and alleviation of diseases, disorders, disabilities, anatomical functions or physiological processes as well as for birth control, and whose primary intended purpose – the effect on the human body – is not achieved by pharmacological, immunological or metabolic means.
Medical devices therefore include everything from ordinary patches, crutches, condoms and pacemakers to electromagnetic and mechanical apparatuses for hospital use, surgical instruments and diagnostic tests.
In Europe, medical devices are a regulated product. They must be produced in accordance with statutory requirements, while being safe and effective. Furthermore, economic operators acting as manufacturers, authorised representatives, distributors, importers, manufacturers of custom-made devices, manufacturers of system and procedure packs, and healthcare institutions have to fulfil their obligations.
Obligations of economic operators are listed in the Regulation (EU) 2017/745 on medical devices, which became applicable on 26 May 2021, and in the Regulation (EU) 2017/746 on in vitro diagnostic medical devices, which will become applicable on 26 May 2022, while some obligations will also be regulated in accordance with national legislations.
- 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.
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Accessories for medical devices are also a subject of the Regulation on medical devices, whereby they are defined as 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).
- Contact lenses or other items intended to be introduced into or onto the eye.
- Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
- Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
- Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
In vitro diagnostic medical devices are also medical devices. They are still regulated in their entirety by the Medical Devices Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 98/09), while the European regulation for this area, i.e. Regulation (EU) 2017/746 on in vitro diagnostic medical devices, will become applicable on 26 May 2022.
The JAZMP is the competent authority for the implementation of tasks deriving from provisions regarding medical devices and the operators involved.