Text · Comparison of two versions
Changes from resolution motion joint to adopted text
RC-10-2024-0123 → TA-10-2024-0028
- From
- RC-10-2024-0123 resolution motion joint of 21 Oct 2024
- To
- TA-10-2024-0028 Adopted text of 23 Oct 2024
- Changes
- 2 changes to the text
- Paragraphs
- +7 added · −2 removed · 0 changed
More facts (2)
- Title (from)
- on the urgent need to revise the Medical Devices Regulation
- Title (to)
- Urgent need to revise the medical devices regulation
AI: What changed, in short Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Changes that matter, 2
Changes to the text in document order — the ones the change notes describe. Cover page, renumbering and punctuation-only edits are left out (see “Every difference”); changes to citations and references stay in and are marked as formal in the notes.
Change 1
AddedO. whereas the innovative regulatory framework referring to substance-based medical devices, which was introduced by the MDR, is intended to encourage the development of therapies that act through non-pharmacological, non-immunological and non-metabolic means; whereas guidelines and decisions issued by national authorities set limits that classify products falling within the scope of the MDR under other regulatory categories, which goes against the EU legislator’s aim of fostering therapeutic innovation;
AddedP. whereas e-health applications of which the purpose corresponds to the definition of medical devices are not currently certified, and therefore potentially endanger users’ health data;
AI: Note on change 1 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds two recitals stating that the MDR's framework for substance-based devices aims to foster innovation, but national guidelines limit it, and that uncertified e-health apps may endanger health data.
Change 2
Added9. Stresses the need to protect health data collected by e-health applications by expressly including these applications in the scope of the revised MDR and by laying down appropriate provisions on them;
AI: Note on change 2 · substance Written by AI from the official text — check the source · deepseek-v4-flash · 4 Sept 2026
Adds a paragraph stressing the need to protect health data from e-health apps by explicitly including them in the revised MDR's scope with appropriate provisions.
Sources & citation
Where the facts on this page come from, and how to cite it.
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2024). “Changes between RC-10-2024-0123 and TA-10-2024-0028”. Text, 23 October 2024. from RC-10-2024-0123, to TA-10-2024-0028. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/RC-10-2024-0123/compare/TA-10-2024-0028 (retrieved 25 September 2026). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).
BibTeX
@misc{epw-text-2024-10-23,
author = {{European Parliament}},
title = {{Changes between RC-10-2024-0123 and TA-10-2024-0028}},
year = {2024},
date = {2024-10-23},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/RC-10-2024-0123/compare/TA-10-2024-0028}},
url = {https://news.eu-parl.st-solutions.dev/texts/RC-10-2024-0123/compare/TA-10-2024-0028},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. from RC-10-2024-0123, to TA-10-2024-0028. Data: European Parliament Open Data (CC BY 4.0)}
}