MDCG 2024-11 Reg­u­la­tion (EU) 2017/745 – appli­ca­tion of MDR require­ments to ‘lega­cy devices’ and to devices placed on the mar­ket pri­or to 26 May 2021 in accor­dance with Direc­tives 90/385/EEC or 93/42/EEC has been updat­ed with revi­sion 1. Basi­cal­ly, changes were due to the updates that were intro­duced by amend­ing Reg­u­la­tion (EU) 2023/607.

MDCG 2024-13 Reg­u­la­to­ry sta­tus of eth­yl­ene oxide (EtO) intend­ed for the ster­il­i­sa­tion of med­ical devices was issued in Octo­ber as well. As the title says, the doc­u­ment pro­vides guid­ance on how EtO is treat­ed from a reg­u­la­to­ry per­spec­tive depend­ing on its appli­ca­tion. As a rule of thumb, where EtO is used for ster­il­i­sa­tion dur­ing the man­u­fac­tur­ing of med­ical devices and IVDs, its use is con­trolled as part of the ster­il­i­sa­tion and val­i­da­tion process­es of the man­u­fac­tur­er, which is in turn sub­ject to MDR/ IVDR con­for­mi­ty assess­ment pro­ce­dures. Where EtO and asso­ci­at­ed ster­il­is­ing equip­ment are used by health insti­tu­tions for ster­il­i­sa­tion before the first use of med­ical devices or after their use to enable their re-use, EtO car­tridges used for the ster­il­i­sa­tion are in scope of the MDR – by virtue of falling under the def­i­n­i­tion of med­ical device or an acces­so­ry. 

MDCG 2022 – 5 Rev. 1 Guid­ance on bor­der­line between med­ical devices and med­i­c­i­nal prod­ucts under Reg­u­la­tion (EU) 2017/745 on med­ical devices has been updat­ed with revi­sion 1 in Octo­ber as well. It adds under sec­tion 1.2.6.1 clar­i­fi­ca­tion that mul­ti­pur­pose dis­in­fec­tants or ster­il­i­sa­tion agents, which are not specif­i­cal­ly intend­ed for the dis­in­fec­tion or ster­il­i­sa­tion of med­ical devices, are cov­ered by the Reg­u­la­tion (EU) 528/2012 on bio­ci­dal products.

Source: Euro­pean Commission

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