The term “medical device” covers all products used to diagnose, prevent, monitor, treat or alleviate diseases, disabilities, anatomical functions or physiological processes, as well as for the control of conception which do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means.
Medical devices therefore cover a wide range of products from simple patches, crutches, corrective glasses, thermometers and condoms to insulin pumps, defibrillators, breast, orthopaedic and dental implants, pacemakers, electromagnetic and mechanical hospital devices, surgical instruments and diagnostic tests.
- 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.
Accessory for a medical device is also subject to the MDR, whereby it is defined therein 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.
Custom-made device means 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.
Medical devices also include in vitro diagnostic medical devices covered by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
As defined in the IVDR, “in vitro diagnostic medical device” means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on on one or more of the following:
- Concerning a physiological or pathological process or state;
- Concerning congenital physical or mental impairments;
- Concerning the predisposition to a medical condition or a disease;
- To determine the safety and compatibility with potential recipients;
- To predict treatment response or reactions;
- To define or monitor therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices. “Specimen receptacle” means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
The IVDR also regulates accessories for in vitro diagnostic medical devices, devices for self-testing, devices for near-patient testing and companion diagnostics.
Accessory for an in vitro diagnostic medical device means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic 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 in vitro diagnostic medical device(s) in terms of its/their intended purpose(s).
Device for self-testing means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services.
Device for near-patient testing means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.
Companion diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:
- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
- identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.
Medical devices are regulated products in the European Union, which must comply with the legal obligations, be safe and effective for their intended use. The obligations must also be fulfilled by economic operators acting as manufacturers, authorised representatives, distributors, importers, manufacturers of custom-made devices, systems and procedure packs producers and health institutions. The obligations of these entities are already set out in the MDR and IVDR, and certain obligations are also regulated at national level in accordance with the Medical Devices Act (Official Gazette of the Republic of Slovenia, No 40/25 with amendments).
The JAZMP is the competent authority for the implementation of tasks deriving from provisions regarding medical devices and the operators involved.
