In June 2026 the Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished MDCG 2026-4, “MDCG Posi­tion Paper: Man­age­ment of SS(C)P in EUDAMED after manda­to­ry use.” It con­firms that respon­si­bil­i­ty for upload­ing the Sum­ma­ry of Safe­ty and Clin­i­cal Per­for­mance (SSCP, MDR) and the Sum­ma­ry of Safe­ty and Per­for­mance (SSP, IVDR) into EUDAMED will shift from noti­fied bod­ies to man­u­fac­tur­ers — and sets out how the han­dover will work.

Cur­rent sta­tus: Since 28 May 2026, the date of manda­to­ry use of the first four EUDAMED mod­ules, noti­fied bod­ies con­tin­ue to upload mas­ter SS(C)Ps when reg­is­ter­ing new or updat­ed cer­tifi­cates. Trans­la­tions are exclud­ed; man­u­fac­tur­ers man­age these in line with MDCG 2021-1 rev.1 (MDR) and MDCG 2022-12 (IVDR).

What changes: MDCG 2019-9 rev.1 is being revised to assign man­u­fac­tur­ers the task of upload­ing both the mas­ter SS(C)P and its trans­la­tions. Man­u­fac­tur­ers must ensure the uploaded ver­sion is the one val­i­dat­ed by the noti­fied body, which will con­firm val­i­da­tion by tick­ing the rel­e­vant Basic UDI-DI(s) at cer­tifi­cate reg­is­tra­tion or link­ing. The same pro­ce­dure applies to SSPs.

Time­lines: The new EUDAMED func­tion­al­i­ty is planned for the Play­ground envi­ron­ment in July 2026 and for Pro­duc­tion in Octo­ber 2026. Noti­fied bod­ies have until 27 May 2027 to upload lega­cy cer­tifi­cates, so gaps between reg­is­tered devices and cer­tifi­cates are expected.

Instruc­tions: The Com­mis­sion orga­nized a webi­nar on July 2. The record­ing is avail­able here.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website