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Ordinary legislative procedure First reading

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

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: In committee: SANT (Public Health) is preparing the report (draft published 30 June 2026).

  1. ✓ Referred to committee 25 March 2026
  2. 2 Committee work SANT (Public Health) preparing the report
  3. 3 Tabled for plenary
  4. 4 Plenary vote
  5. 5 Negotiations with the Council
  6. 6 Published as law
How a file moves through Parliament

A file is referred to one lead committee (others may give an opinion). Its rapporteur writes a draft report, committee members table amendments, and the committee votes to adopt the report. The report is then tabled for all MEPs; political groups can table further amendments, which are voted on before the final vote in plenary. For a law, Parliament’s adopted text is its first-reading position; Parliament and the Council then negotiate a common text (trilogues) which both must approve before it is published as law.

Who is working on it

Lead committee
SANT — Public Health
Rapporteur
Oliver SCHENK PPE
Shadow rapporteurs
Tiemo WÖLKEN S&DMEP #256921 PfERuggero RAZZA ECRAndreas GLÜCK RenewIgnazio Roberto MARINO Verts/ALEValentina PALMISANO The LeftChristine ANDERSON ESN
For opinion
IMCO — Internal Market and Consumer Protection · rapporteur Anna CAVAZZINI Verts/ALE

The rapporteur drafts and negotiates the text for the lead committee; each other political group names a shadow rapporteur to follow the file.

The text, version by version

Committee draft · latest Draft report (SANT) 30 June 2026 ✦ 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)

Newest version first. Open a version to read it in full. “What changed” shows the differences paragraph by paragraph; ✦ lines are AI-written from the texts themselves.

Timeline

  1. Committee stage
  2. 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)
  3. 30 June 2026 Draft report published

    The rapporteur’s first text in SANT (Public Health). Members can table amendments before the committee votes.

    📄 Draft report (SANT)
  4. 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.