On 17 June 2026 the Offi­cial Jour­nal of the EU pub­lished two Com­mis­sion Imple­ment­ing Deci­sions extend­ing the har­monised stan­dards lists for med­ical devices and in vit­ro diag­nos­tics. Both entered into force on the day of publication.

Imple­ment­ing Deci­sion (EU) 2026/1231 (11 June 2026) does two things. First, it replaces five exist­ing entries with their 2025 amend­ments: EN ISO 10993-23, -12 and -17 (bio­log­i­cal eval­u­a­tion), EN IEC 60601-2-83 (home light ther­a­py equip­ment) and EN ISO 15223-1 (sym­bols). Sec­ond, it adds 14 new ref­er­ences, cov­er­ing trans­fu­sion sets (EN ISO 1135-4/-5:2025), bio­log­i­cal eval­u­a­tion (EN ISO 10993-1:2025; EN ISO 10993-5:2009/A11:2025), oph­thalmic optics (EN ISO 14889:2025), mam­ma­ry implants (EN ISO 14607:2025), wash­er-dis­in­fec­tors (EN ISO 15883-1/-2/-3/-7:2025), pros­thet­ics (EN ISO 22675:2025), sharps injury pro­tec­tion (EN ISO 23908:2025), and EN 60601-1:2006/A13:2024.

Imple­ment­ing Deci­sion (EU) 2026/1313 (15 June 2026) makes the equiv­a­lent sin­gle change under IVDR, adding EN ISO 15223-1:2021/A1:2025 to Deci­sion (EU) 2021/1195.

As stat­ed in numer­ous pre­vi­ous posts and announce­ments, the autho­rised rep­re­sen­ta­tive sym­bol is chang­ing under this regime for both med­ical devices reg­u­la­tions (MDR and IVDR). Amend­ment EN ISO 15223-1:2021/A1:2025 replaces the out­dat­ed “EC REP” (Euro­pean Com­mu­ni­ty) with “EU REP,” align­ing the sym­bol with today’s Euro­pean Union. 

The change is pure­ly edi­to­r­i­al: no impact on device safe­ty, per­for­mance, or the role and oblig­a­tions of the autho­rised rep­re­sen­ta­tive, and no pri­or noti­fied body approval is need­ed for the labelling update.

A 5-year tran­si­tion peri­od runs until 17 June 2031, dur­ing which both “EC REP” and “EU REP” may be used. From that date, only “EU REP” applies; devices already on the mar­ket with “EC REP” may remain available.

The Com­mis­sion pub­lished a sep­a­rate guid­ance doc­u­ment, MDCG 2021-5 rev. 1-Appen­dix in this context. 

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website