Ionising radiation

MDCG cites this Euratom definition for the MDR classification rules. Active devices that emit ionising radiation for diagnostic or therapeutic radiology are class IIb under Rule 10.

‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less (a frequency of 3 × 10¹⁵ hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).

MDCG 2021-24 Rev.1, Section 4.2, Rule 9, Practical issues of classification, Note 2 (citing Directive 2013/59/EURATOM)