Dossier · Ordinary legislative procedure
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
- Reference
- 2025/0404(COD) Ordinary legislative procedure
- Where it stands
- In committee: SANT (Public Health) is preparing the report (draft published 30 June 2026).
- Stage
- First reading
- Lead committee
- Public Health SANT
Where it stands
The steps of this kind of dossier and how far it has come, from the procedure file.
- Referred to committee (done) 25 March 2026
- Committee work (current step) 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)
A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.
People
Committees and members responsible for the dossier, as the procedure file names them. Groups as recorded there.
- Lead committee
- Public Health SANT
- Rapporteur
- Oliver SCHENK (EPP)
- Shadow rapporteurs
- Tiemo WÖLKEN (S&D), Laurent CASTILLO (Patriots), Ruggero RAZZA (ECR), Andreas GLÜCK (Renew), Ignazio Roberto MARINO (Greens), Valentina PALMISANO (The Left), Christine ANDERSON (ESN)
- Opinion: IMCO
- Internal Market and Consumer Protection · rapporteur Maria GUZENINA (S&D)
Decisions in plenary, 0
Every decision Parliament took on this dossier, newest first.
No plenary decision on this dossier is in the records yet.
Every roll-call vote on the dossier, in date and voting order, with each group's line at the date of the vote.
No roll-call vote was recorded on this dossier.
Add members’ columns
Versions, 1
The text of the dossier, version by version, newest first. Compare shows what changed between two consecutive versions.
Committee draft30 Jun 2026
Draft report (SANT) SANT-PR-787987
AI: Each version in short Written by AI from the official text — check the source
- Draft report (SANT): The draft report is the rapporteur's first version of Parliament's position on a proposal to simplify the rules on medical devices and in vitro diagnostic medical devices. It keeps patient safety safeguards while reducing administrative burden, clarifying regulatory status and classification, and adapting rules for breakthrough, orphan and niche devices.
Committee opinions: Draft opinion (IMCO), Draft opinion (BUDG)
What changed
Between consecutive versions of the text, newest pair first.
No overview of what changed between versions is available for this dossier — fewer than two versions of its text are linked in the open data.
Timeline, 3
Every recorded step, newest first, grouped by stage; the latest stage is open.
Committee stage 3 steps · 25 Mar 2026–28 Jul 2026
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.
Connections
Texts, decisions, people and other dossiers related to this one.
No connections found for this item.
Sources & citation
Where the facts on this page come from, and how to cite it.
- Official source
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “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”. Dossier. reference 2025/0404(COD). EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/dossiers/2025-0404 (retrieved 25 September 2026). Official source: Legislative Observatory (OEIL), 2025/0404(COD), https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2025%2F0404(COD). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).
BibTeX
@misc{epw-dossier-2025-0404,
author = {{European Parliament}},
title = {{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}},
year = {2026},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/dossiers/2025-0404}},
url = {https://news.eu-parl.st-solutions.dev/dossiers/2025-0404},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Dossier. reference 2025/0404(COD). Official source: https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2025\%2F0404(COD). Data: European Parliament Open Data (CC BY 4.0)}
}