What does an auditor check for IEC 62366?
EN 62366-1:2015 + A1:2020 · What the EU MDR requires — and what only your licensed copy of the standard can tell you
The short answer
The requirement you are assessed against is in the Regulation, not in the standard. Section 5 of Chapter I of Annex I of Regulation (EU) 2017/745 has two parts: in eliminating or reducing risks related to use error, the risks related to the ergonomic features of the device and the environment in which it is intended to be used are to be reduced as far as possible (point (a)), and the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of the intended users are to be given consideration (point (b)). And under Section 3 (c) of the same Chapter, the risks occurring during reasonably foreseeable misuse are estimated and evaluated like any other risk. EN 62366-1:2015 + A1:2020 — Medical devices, Application of usability engineering to medical devices — is the standard that describes a process for that. The Commission has requested its revision as an existing harmonised standard (standardisation request C(2021) 2406, Annex I, Table 1, no. 180); as of 17 June 2026 it is not cited in the Official Journal under the MDR, so applying it gives no presumption of conformity — what it gives you is a documented process. ISO 14971:2019 refers to it at two points: the use specification can be an input to the intended use (clause 5.2), and testing with users can be part of verifying that a risk control measure is effective (clause 7.2). What the usability process itself has to contain is in the standard; we do not reproduce it here.
Frequently asked questions
Does the MDR require me to apply IEC 62366-1?
No. The Regulation requires the outcome Section 5 of Chapter I of Annex I describes, not a named standard. A harmonised standard whose reference is published in the Official Journal gives you a presumption of conformity for the requirements it covers — that is Article 8(1), and the Commission restates it in recital 1 of Implementing Decision (EU) 2022/757; EN 62366-1 is not on that list as of 17 June 2026. You can apply it, but the evidence that the requirement is met stays yours to argue in your own file.
Where does the checklist for my usability engineering file come from?
From your own licensed copy of IEC 62366-1. The standard's text is copyrighted and we do not have it in house, so we do not list its documents or clauses here — a checklist assembled from memory or from blogs is exactly what puts wrong clause numbers into files. What any one notified body will focus on in an audit is not something we will tell you either; we do not know it.