# Medical devices

European Parliament procedure 2012/0266(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 7th term, committee EMPL / ENVI / IMCO). Stage: Procedure completed. 933 committee amendments tabled by 53 Members between 2013-04-26 and 2013-05-17.

## What the amendments focus on

A regulation on medical devices aimed at the internal market and a high level of health and safety for patients, users, operators and health professionals. The amendments reinforce supervision of notified bodies, conformity assessment, clinical investigations, vigilance and market surveillance, define corrective action, field safety corrective action and field safety notice, address nanomaterials, a central database with UDI, importer obligations, and reporting of serious incidents by healthcare professionals and patients.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Mairead McGUINNESS | Ireland | PPE | 104 | https://amendeu.com/md/meps/28115.md |
| Thomas ULMER | Germany | PPE | 101 | https://amendeu.com/md/meps/28221.md |
| Holger KRAHMER | Germany | ALDE | 94 | https://amendeu.com/md/meps/28247.md |
| Nora BERRA | France | PPE | 77 | https://amendeu.com/md/meps/96947.md |
| Marina YANNAKOUDAKIS | United Kingdom | ECR | 54 | https://amendeu.com/md/meps/96944.md |
| Anna ROSBACH | Denmark | ECR | 47 | https://amendeu.com/md/meps/96664.md |
| Peter LIESE | Germany | PPE | 44 | https://amendeu.com/md/meps/1927.md |
| Michèle RIVASI | France | Verts/ALE | 41 | https://amendeu.com/md/meps/96743.md |
| Andreas SCHWAB | Germany | PPE | 41 | https://amendeu.com/md/meps/28223.md |
| Corinne LEPAGE | France | ALDE | 40 | https://amendeu.com/md/meps/97076.md |
| António Fernando CORREIA DE CAMPOS | France | S&D | 40 | https://amendeu.com/md/meps/96975.md |
| Zofija MAZEJ KUKOVIČ | Slovenia | PPE | 38 | https://amendeu.com/md/meps/39916.md |
| Antonyia PARVANOVA | Bulgaria | ALDE | 33 | https://amendeu.com/md/meps/34234.md |
| Philippe JUVIN | France | PPE | 32 | https://amendeu.com/md/meps/96884.md |
| Milan CABRNOCH | Czechia | ECR | 24 | https://amendeu.com/md/meps/28324.md |

## Official source documents

- PE510.536: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.536+01+DOC+PDF+V0//EN&language=EN
- PE510.666: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.666+02+DOC+PDF+V0//EN&language=EN
- PE510.741: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.741+01+DOC+PDF+V0//EN&language=EN
- PE510.765: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.765+01+DOC+PDF+V0//EN&language=EN
- PE510.766: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.766+01+DOC+PDF+V0//EN&language=EN
- PE510.767: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.767+01+DOC+PDF+V0//EN&language=EN

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2012-0266-COD · machine-readable: https://amendeu.com/data/dossiers/2012-0266-COD.json

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Data refreshed: 2026-07-27. Human-readable version: https://amendeu.com/dossiers/2012-0266-COD
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