The Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished a num­ber of guid­ance doc­u­ments lately. 

MDCG 2024-10, Clin­i­cal eval­u­a­tion of orphan med­ical devices, pro­vides advice for gen­er­at­ing clin­i­cal data for devices that are intend­ed for use in rare diseases/conditions or spe­cif­ic indi­ca­tions for rare cohorts of patients with non-rare diseases/conditions. More specif­i­cal­ly, it address­es ques­tions like, “How does a man­u­fac­tur­er jus­ti­fy orphan device sta­tus?” or “What type of facil­i­ties are grant­ed for orphan devices?” 

MDCG 2021-5, rev. 1, Guid­ance on stan­dard­i­s­a­tion for med­ical devices, is an update to the doc­u­ment that was ini­tial­ly pub­lished in 2021. It pro­vides amend­ments and sup­ple­ments to the ini­tial release. For exam­ple, MDCG 2021-5, rev. 1, con­tains rel­e­vant court rul­ings in the con­text of stan­dard­iza­tion and updates on the con­cept of “state of the art”.

MDCG 2020-16, rev. 3, Guid­ance on Clas­si­fi­ca­tion Rules for in vit­ro Diag­nos­tic Med­ical Devices under Reg­u­la­tion (EU) 2017/746, is a new update to the doc­u­ment that was ini­tial­ly pub­lished in 2020. It pro­vides guid­ance on the clas­si­fi­ca­tion of IVD med­ical devices. Revi­sion 3 con­tains a num­ber of edi­to­r­i­al changes and revised exam­ples. In addi­tion, MDCG 2020-16, rev. 3, also adds the def­i­n­i­tion of a kit.

The MDCG also pub­lished 2024-1-5, Guid­ance on the vig­i­lance sys­tem for CE-marked devices, DSVG 05, Urog­y­nae­co­log­i­cal Sur­gi­cal Mesh Implants used for Pelvic Organ Pro­lapse repair and Stress Uri­nary Incon­ti­nence. It pro­vides spe­cif­ic advice for han­dling the afore­men­tioned devices with­in a manufacturer’s vig­i­lance system.

The doc­u­ments can be accessed in our down­load sec­tion.

Source: Euro­pean Commission

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