User

Who counts as a user shapes the human factors work and the information supplied, since a cleaner or installer can make errors too.

‘user’ means any healthcare professional or lay person who uses a device;

EU MDR, Article 2(37)

‘user’ means any healthcare professional or lay person who uses a device;

IVDR, Article 2(30)

person interacting with the HEALTH SOFTWARE PRODUCT Note 1 to entry: In general, a USER is not considered to be a RESPONSIBLE ORGANIZATION, except for consumer type HEALTH SOFTWARE PRODUCTS, e.g., for personal health applications, or products to be used by lay persons.

IEC 82304-1:2016, clause 3.22

person interacting with (i.e. operating or handling) the MEDICAL DEVICE Note 1 to entry: There can be more than one USER of a MEDICAL DEVICE. Note 2 to entry: Common USERS include clinicians, PATIENTS, cleaners, maintenance and service personnel.

IEC 62366-1:2015+AMD1:2020, clause 3.24

User is defined as person using, i.e. operating or handling, the medical device (section 3.24) o Note 1 This includes, but is not limited to, cleaners, maintainers and installers. o Note 2 Patients or other laypersons can be users.

MDCG 2021-6 Rev.1, Question 17 (quoting EN 62366-1)

For the purpose of this document, the ‘user’ (Article 2(37) MDR/Article 2(30) IVDR) is any healthcare institution, healthcare professional or layperson (e.g., caregiver, patient) who uses the device, or persons responsible for installing or maintaining the device.

MDCG 2023-3 Rev.2, Question 4

Person interacting with (i.e., operating or handling) the medical device.

FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (August 2026), Section 3, Definitions

The MDR and IVDR limit user to healthcare professionals and lay persons who use a device. MDCG 2023-3 widens it for vigilance to healthcare institutions and people who install or maintain the device, and the IEC 62366-1 definition quoted in MDCG 2021-6 includes cleaners, maintainers and installers. The FDA human factors guidance speaks of any person operating or handling the device.