# In vitro diagnostic medical devices

European Parliament procedure 2012/0267(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 7th term, committee EMPL / ENVI / IMCO). Stage: Procedure completed. 403 committee amendments tabled by 36 Members between 2013-04-26 and 2013-05-13.

## What the amendments focus on

A proposal on in vitro diagnostic medical devices. Amendments address protection of health for patients, professionals and users, supervision of notified bodies and conformity assessment by device class, the Unique Device Identification system and the Eudamed database, vigilance and field safety corrective actions, clinical performance studies and ethics committees, in-house devices made within health institutions, and transparency for patients.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Dagmar ROTH-BEHRENDT | Germany | S&D | 124 | https://amendeu.com/md/meps/1183.md |
| Margrete AUKEN | Denmark | Verts/ALE | 51 | https://amendeu.com/md/meps/28161.md |
| Alda SOUSA | Portugal | GUE/NGL | 42 | https://amendeu.com/md/meps/113487.md |
| António Fernando CORREIA DE CAMPOS | France | S&D | 42 | https://amendeu.com/md/meps/96975.md |
| Anna ROSBACH | Denmark | ECR | 29 | https://amendeu.com/md/meps/96664.md |
| Peter LIESE | Germany | PPE | 27 | https://amendeu.com/md/meps/1927.md |
| Rebecca TAYLOR | United Kingdom | ALDE | 25 | https://amendeu.com/md/meps/112620.md |
| Milan CABRNOCH | Czechia | ECR | 22 | https://amendeu.com/md/meps/28324.md |
| Thomas ULMER | Germany | PPE | 21 | https://amendeu.com/md/meps/28221.md |
| Anja WEISGERBER | Germany | PPE | 19 | https://amendeu.com/md/meps/28227.md |
| Antonyia PARVANOVA | Bulgaria | ALDE | 16 | https://amendeu.com/md/meps/34234.md |
| Paolo BARTOLOZZI | Italy | PPE | 12 | https://amendeu.com/md/meps/21818.md |
| Anne DELVAUX | Belgium | PPE | 12 | https://amendeu.com/md/meps/96914.md |
| Renate SOMMER | Germany | PPE | 10 | https://amendeu.com/md/meps/4282.md |
| Miroslav MIKOLÁŠIK | Slovakia | PPE | 9 | https://amendeu.com/md/meps/28178.md |

## Official source documents

- PE510.535: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN
- PE510.668: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN
- PE510.740: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN
- PE510.755: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2012-0267-COD · machine-readable: https://amendeu.com/data/dossiers/2012-0267-COD.json

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Source: AmendEU (amendeu.com), built from Parltrack (ODbL), European Parliament Open Data ((c) European Union) and official Parliament documents. Aggregates CC BY 4.0.
Data refreshed: 2026-07-27. Human-readable version: https://amendeu.com/dossiers/2012-0267-COD
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