Where the law stands, Dossier 2025/0404(COD)
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
Ordinary legislative procedure (COD): Parliament and the Council decide together as equals. · First reading
A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.
Where it stands
Committee work
In committee: SANT (Public Health) is preparing the report (draft published 30 June 2026).
- Referred to committee(done) 25 March 2026
- Committee work SANT (Public Health) preparing the report
- Tabled for plenary(to come)
- Plenary vote(to come)
- Negotiations with the Council(to come)
- Published as law(to come)
No plenary decision on this dossier is in our records yet.
Who works on it
- Lead committee
- Public Health
- The MEP who drafts the report and negotiates it on behalf of the committee.
- Oliver Schenk (EPP)
- An MEP who follows a report on behalf of their own group when another group holds the rapporteur.
- Tiemo Wölken (S&D), Laurent Castillo (Patriots), Ruggero Razza (ECR), Andreas Glück (Renew), Ignazio Roberto Marino (Greens), Valentina Palmisano (The Left), Christine Anderson (ESN)
- Committees giving an opinion
- Internal Market and Consumer Protection· rapporteurMaria Guzenina (S&D)
The text, version by version
Newest first.
Committee draft· 30 Jun 2026
Committee opinions: Draft opinion (IMCO), Draft opinion (BUDG)
Timeline
Newest first.
Committee stage 3 steps
28 July 2026
Amendments tabled in committee (3 batches)
Members of SANT (Public Health) proposed changes to the draft.
Amendments in committee (SANT)Amendments in committee (SANT)Amendments in committee (SANT)
30 June 2026
Draft report published
The rapporteur’s first text in SANT (Public Health). Members can table amendments before the committee votes.
25 March 2026
Referred to the SANT (Public Health) committee
The lead committee prepares the report; IMCO (Internal Market and Consumer Protection) gives an opinion.
Official record: Legislative Observatory, 2025/0404(COD)