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 became applicable on 26 May 2022, while some obligations will also be regulated in accordance with national legislations in the Medical Devices Act.
- 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) of the MDR and of those referred to in the first paragraph of point (1) of Article 2 of the MDR.
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.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereinafter IVDR), became applicable on 26 May 2022.
According to the definition from 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 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 monitoring therapeutic measures.
Specimen receptacles also be deemed to be in vitro diagnostic medical devices, 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.
The JAZMP is the competent authority for the implementation of tasks deriving from provisions regarding medical devices and the operators involved.