Procedure
In vitro diagnostic medical devices
2012/0267(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): LIESE Peter (PPE)
Summary
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.
Procedure timeline
- Committee amendments tabled26 Apr 2013 – 13 May 2013
- Procedure completed
403
Amendments
distinct, in window
36
Members
tabled at least one
3
Committees
26 Apr 2013 – 13 May 2013
Dates
Official amendment documents
Connections
Related procedures
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European Partnership on Metrology
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Non-automatic weighing instruments: making available on the market. Recast. 'Goods package'
7th term · Precision engineering, optics, photography, medical · Standardisation, EC/EU standards and trade mark, certification, compliance
45amendments
Measuring instruments: making available on the market. Recast. 'Goods package'
7th term · Precision engineering, optics, photography, medical · Standardisation, EC/EU standards and trade mark, certification, compliance
32amendments
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Members who amended this procedure
36 Members · by amendment count1
Dagmar ROTH-BEHRENDT
Socialists & Democrats · 🇩🇪 Germany
124(124 solo)
2Margrete AUKEN
Greens / EFA · 🇩🇰 Denmark
51(42 solo)
3Alda SOUSA
The Left (GUE/NGL) · 🇵🇹 Portugal
42(34 solo)
4António Fernando CORREIA DE CAMPOS
Socialists & Democrats · 🇫🇷 France
42(42 solo)
5Anna ROSBACH
European Conservatives & Reformists · 🇩🇰 Denmark
29(15 solo)
6Peter LIESE
European People's Party (EPP) · 🇩🇪 Germany
27(12 solo)
7Rebecca TAYLOR
ALDE · 🇬🇧 United Kingdom
25(20 solo)
8Milan CABRNOCH
European Conservatives & Reformists · 🇨🇿 Czechia
22(22 solo)
9Thomas ULMER
European People's Party (EPP) · 🇩🇪 Germany
21
10Anja WEISGERBER
European People's Party (EPP) · 🇩🇪 Germany
19(7 solo)
11Antonyia PARVANOVA
ALDE · 🇧🇬 Bulgaria
16(16 solo)
12Paolo BARTOLOZZI
European People's Party (EPP) · 🇮🇹 Italy
12
13Anne DELVAUX
European People's Party (EPP) · 🇧🇪 Belgium
12
14Renate SOMMER
European People's Party (EPP) · 🇩🇪 Germany
10
15Miroslav MIKOLÁŠIK
European People's Party (EPP) · 🇸🇰 Slovakia
9
16Philippe BOULLAND
European People's Party (EPP) · 🇫🇷 France
8(8 solo)
17Nora BERRA
European People's Party (EPP) · 🇫🇷 France
8(6 solo)
18Zofija MAZEJ KUKOVIČ
European People's Party (EPP) · 🇸🇮 Slovenia
7
19Christofer FJELLNER
European People's Party (EPP) · 🇸🇪 Sweden
6(1 solo)
20Marina YANNAKOUDAKIS
European Conservatives & Reformists · 🇬🇧 United Kingdom
5
21Linda McAVAN
Socialists & Democrats · 🇬🇧 United Kingdom
4
22Jolanta Emilia HIBNER
European People's Party (EPP) · 🇵🇱 Poland
4(4 solo)
23Christel SCHALDEMOSE
Socialists & Democrats · 🇩🇰 Denmark
3
24Andrés PERELLÓ RODRÍGUEZ
Socialists & Democrats · 🇪🇸 Spain
3(3 solo)
25Mairead McGUINNESS
European People's Party (EPP) · 🇮🇪 Ireland
2
The amendments, in full text
403 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.