Various guidance and documents published on the European Commission (EC) website provide explanations for all economic operators involved in any way with medical devices and who are subject to Regulation (EU) 2017/745 on medical devices (MDR), which became applicable on 26 May 2021, and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which became applicable on 26 May 2022.
The guidance documents are prepared and adopted within the Medical Device Coordination Group (MDCG) and its subgroups, in which all relevant stakeholders participate alongside representatives of the Member States. The guidance documents ensure a harmonised understanding and effective implementation of the MDR and the IVDR Regulations. The use of the guidance documents is not legally binding, but it is recommended as they facilitate the practical application of the MDR and the IVDR Regulations and provide clarity regarding their obligations. The content presented below is intended to guide users to the relevant guidance document. The applicable content is the one contained in the latest versions of the guidance documents published on the website: Guidance – MDCG endorsed documents and other guidance.
What are medical devices?
The Regulation (EU) 2017/745 on medical devices (MDR) as the main regulation in the field of medical devices defines medical devices as 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.
Medical devices also include devices for the control or support of conception and products specifically intended for the cleaning, disinfection or sterilisation of devices. Accessories for medical devices and products without an intended medical purpose listed in Annex XVI are also a subject to the Regulation on medical devices.
Medical devices also include in vitro diagnostic medical devices regulated by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
