Procedure
In vitro diagnostic medical devices
2012/0267(COD)·7th term·EMPL / ENVI / IMCO·COD - Ordinary legislative procedure (ex-codecision procedure)·CompletedProcedure 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
Committee(s)
26 Apr 2013 – 13 May 2013
Dates
Official amendment documents
Connections
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Members who amended this procedure
36 Members · by amendment count1🇩🇪
Dagmar ROTH-BEHRENDT
Socialists & Democrats · Germany
124(124 solo)
2🇩🇰Margrete AUKEN
Greens / EFA · Denmark
51(42 solo)
3🇵🇹Alda SOUSA
The Left (GUE/NGL) · Portugal
42(34 solo)
4🇫🇷António Fernando CORREIA DE CAMPOS
Socialists & Democrats · France
42(42 solo)
5🇩🇰Anna ROSBACH
European Conservatives & Reformists · Denmark
29(15 solo)
6🇩🇪Peter LIESE
European People's Party (EPP) · Germany
27(12 solo)
7🇬🇧Rebecca TAYLOR
ALDE · United Kingdom
25(20 solo)
8🇨🇿Milan CABRNOCH
European Conservatives & Reformists · Czechia
22(22 solo)
9🇩🇪Thomas ULMER
European People's Party (EPP) · Germany
21
10🇩🇪Anja WEISGERBER
European People's Party (EPP) · Germany
19(7 solo)
11🇧🇬Antonyia PARVANOVA
ALDE · Bulgaria
16(16 solo)
12🇮🇹Paolo BARTOLOZZI
European People's Party (EPP) · Italy
12
13🇧🇪Anne DELVAUX
European People's Party (EPP) · Belgium
12
14🇩🇪Renate SOMMER
European People's Party (EPP) · Germany
10
15🇸🇰Miroslav MIKOLÁŠIK
European People's Party (EPP) · Slovakia
9
16🇫🇷Philippe BOULLAND
European People's Party (EPP) · France
8(8 solo)
17🇫🇷Nora BERRA
European People's Party (EPP) · France
8(6 solo)
18🇸🇮Zofija MAZEJ KUKOVIČ
European People's Party (EPP) · Slovenia
7
19🇸🇪Christofer FJELLNER
European People's Party (EPP) · Sweden
6(1 solo)
20🇬🇧Marina YANNAKOUDAKIS
European Conservatives & Reformists · United Kingdom
5
21🇬🇧Linda McAVAN
Socialists & Democrats · United Kingdom
4
22🇵🇱Jolanta Emilia HIBNER
European People's Party (EPP) · Poland
4(4 solo)
23🇩🇰Christel SCHALDEMOSE
Socialists & Democrats · Denmark
3
24🇪🇸Andrés PERELLÓ RODRÍGUEZ
Socialists & Democrats · Spain
3(3 solo)
25🇮🇪Mairead 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.
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