Imple­ment­ing Deci­sion (EU) 2025/1324 on Expert Pan­els for Orphan Devices

Back­ground

Com­mis­sion Imple­ment­ing Deci­sion (EU) 2019/1396 orig­i­nal­ly estab­lished expert pan­els to advise on high-risk med­ical devices under the Med­ical Devices Reg­u­la­tion (MDR), arti­cle 106(1). Since its entry into force, key devel­op­ments trig­gered the need for amend­ment, espe­cial­ly expe­ri­ence revealed a gap in advice for pae­di­atric and rare-dis­ease device needs.

Pur­pose of Imple­ment­ing Deci­sion (EU) 2025/1324

Adopt­ed 7 July 2025 and effec­tive 28 July 2025, it amends 2019/1396 to:

1. Des­ig­nate a new pan­el for med­ical devices and IVD med­ical devices tar­get­ing pae­di­atric and rare-dis­ease populations.
2. Stream­line admin­is­tra­tion by allow­ing tem­po­rary assign­ment of advi­sors across pan­els, enabling per­ma­nent or ad hoc sub-groups, clar­i­fy­ing roles for rap­por­teurs and review­ers, man­dat­ing pub­lic rules of pro­ce­dure, and stan­dard­iz­ing time­lines and expert remuneration.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Imple­ment­ing reg­u­la­tions on eIFU, well-estab­lished tech­nolo­gies and orphan/ pedi­atric devices in sight
• Indus­try and pol­i­cy­mak­ers push for med­ical tech­nol­o­gy reg­u­la­to­ry reforms in the EU
• Is a cen­tralised gov­er­nance agency for med­ical devices feasible?