On amendments to Appendices No. 1 and No. 2 to the Order of the Ministry of Health of the Russian Federation dated June 6, 2012 No. 4n “On approval of the nomenclature classification of medical devices”

The Federal Service for Surveillance in Healthcare informs that on August 10, 2020, the Ministry of Justice of the Russian Federation registered the order of the Ministry of Health of the Russian Federation dated 07.07.2020 No. 686n “On amendments to Appendices No. 1 and No. 2 to the order of the Ministry of Health of the Russian Federation dated 6 June 2012 No. 4n “On Approval of the Nomenclature Classification of Medical Devices” (registration No. 59225) This regulatory legal act provides for the introduction of a separate section on the classification of software that is a medical device, depending on the potential risk of its use, as well as group B nomenclature classification of medical devices by type.

We note that the approach to the classification of software that is a medical device, depending on the potential risk of its use, presented in this order, is harmonized with the approaches described in the documents of the International Medical Device Regulatory Forum (IMDRF).