Procedure
Medical devices
2012/0266(COD)·7th term·EMPL / ENVI / IMCO·COD - Ordinary legislative procedure (ex-codecision procedure)·Completed
Subjects: Standardisation, EC/EU standards and trade mark, certification, compliance · Precision engineering, optics, photography, medical · Health legislation and policy · Safety of products and services, product liability
Rapporteur (the Member appointed to lead Parliament's work on this text): WILLMOTT Dame Glenis (S&D)
Summary
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.
Procedure timeline
- Committee amendments tabled26 Apr 2013 – 17 May 2013
- Procedure completed
933
Amendments
distinct, in window
53
Members
tabled at least one
3
Committees
26 Apr 2013 – 17 May 2013
Dates
Official amendment documents
Connections
Related procedures
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32amendments
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Members who amended this procedure
53 Members · by amendment count1
Mairead McGUINNESS
European People's Party (EPP) · 🇮🇪 Ireland
104(80 solo)
2Thomas ULMER
European People's Party (EPP) · 🇩🇪 Germany
101(66 solo)
3Holger KRAHMER
ALDE · 🇩🇪 Germany
94(93 solo)
4Nora BERRA
European People's Party (EPP) · 🇫🇷 France
77(77 solo)
5Marina YANNAKOUDAKIS
European Conservatives & Reformists · 🇬🇧 United Kingdom
54(26 solo)
6Anna ROSBACH
European Conservatives & Reformists · 🇩🇰 Denmark
47(10 solo)
7Peter LIESE
European People's Party (EPP) · 🇩🇪 Germany
44(19 solo)
8Michèle RIVASI
Greens / EFA · 🇫🇷 France
41(12 solo)
9Andreas SCHWAB
European People's Party (EPP) · 🇩🇪 Germany
41(41 solo)
10Corinne LEPAGE
ALDE · 🇫🇷 France
40(11 solo)
11António Fernando CORREIA DE CAMPOS
Socialists & Democrats · 🇫🇷 France
40(40 solo)
12Zofija MAZEJ KUKOVIČ
European People's Party (EPP) · 🇸🇮 Slovenia
38(8 solo)
13Antonyia PARVANOVA
ALDE · 🇧🇬 Bulgaria
33(33 solo)
14Philippe JUVIN
European People's Party (EPP) · 🇫🇷 France
32(32 solo)
15Milan CABRNOCH
European Conservatives & Reformists · 🇨🇿 Czechia
24(24 solo)
16Gilles PARGNEAUX
Socialists & Democrats · 🇫🇷 France
22(22 solo)
17Rebecca TAYLOR
ALDE · 🇬🇧 United Kingdom
22(22 solo)
18Marian HARKIN
ALDE · 🇮🇪 Ireland
21(21 solo)
19Anja WEISGERBER
European People's Party (EPP) · 🇩🇪 Germany
21(9 solo)
20Mara BIZZOTTO
Identity & Democracy · 🇮🇹 Italy
19(19 solo)
21Philippe BOULLAND
European People's Party (EPP) · 🇫🇷 France
13(13 solo)
22Christel SCHALDEMOSE
Socialists & Democrats · 🇩🇰 Denmark
13(9 solo)
23Horst SCHNELLHARDT
European People's Party (EPP) · 🇩🇪 Germany
12(12 solo)
24Christofer FJELLNER
European People's Party (EPP) · 🇸🇪 Sweden
12(3 solo)
25Alda SOUSA
The Left (GUE/NGL) · 🇵🇹 Portugal
12(12 solo)
The amendments, in full text
933 amendmentsEvery amendment as tabled — original text, proposed change and justification, with a link to the official PDF.
The full amendment texts load as you scroll here.