CHMP opinions on consultation procedures

The European Medicines Agency (EMA) publishes a consultation procedure public assessment report (CPAR) on the opinions prepared by its Committee for Medicinal Products for Human Use (CHMP) following a consultation procedure with EMA on the quality, safety, benefits and risks of ancillary substances incorporated in a medical device.

EMA publishes the CPAR after the notified body confirms the granting of a Conformité Européenne (CE) mark for the device.

The Agency also publishes information on procedural steps taken after a consultation procedure.

For more information on the consultation procedure, see Ancillary medicinal substances in medical devices.

CHMP opinions

Name of medical device CooperSurgical Inc ART Media
Ancillary substance Human albumin
Manufacturer Cooper Surgical Inc
Notified body British Standards Institutions (BSI)
CHMP opinion PDF iconCPAR - CooperSurgical Inc ART Media
Date of opinion 19/02/2011
Active review time (days) 210
Steps after consultation (last updated) PDF iconCooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical device COOK IVF cell media
Ancillary substance Human albumin solution
Manufacturer William Cook Australia Pty Ltd
Notified body Det Norske Veritas Certification AS
CHMP opinion PDF iconCPAR - COOK IVF cell media
Date of opinion 16/02/2012
Active review time (days) 180
Steps after consultation (last updated) PDF iconCOOK IVF cell media - Procedural steps and scientific information after initial consultation (11/01/2018)
Name of medical device FertiPro N.V. HSA-containing ART media
Ancillary substance Human albumin solution
Manufacturer FertiPro N.V.
Notified body DEKRA Certification
CHMP opinion PDF iconCPAR - FertiPro N.V. HSA-containing ART media
Date of opinion 19/01/2012
Active review time (days) 210
Steps after consultation (last updated) PDF iconFertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical device Floseal haemostatic matrix (Floseal VH S/D)
Ancillary substance Human thrombin
Manufacturer Baxter AG
Notified body TÜV SÜD Product Service GmbH
CHMP opinion PDF iconCPAR - Floseal haemostatic matrix (Floseal VH S/D)
Date of opinion 19/02/2009
Active review time (days) 204
Steps after consultation (last updated) PDF iconFloseal hemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical device Gems Medium Suite
Ancillary substance Human serum albumin
Manufacturer Genea Biomedx UK Ltd
Notified body British Standards Institutions (BSI)
CHMP opinion PDF iconCPAR - Gems Medium Suite
Date of opinion 23/04/2015
Active review time (days) 210
Steps after consultation (last updated) PDF iconGems Medium Suite - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical device Hemoblast
Ancillary substance Human thrombin
Manufacturer Biom'Up
Notified body British Standard Institute Group
CHMP opinion PDF iconCPAR - Hemoblast
Date of opinion 25/09/2014
Active review time (days) 210
Steps after consultation (last updated) PDF iconHemoblast - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical device Irvine Scientific Reproductive Media
Ancillary substance Human albumin
Manufacturer Irvine Scientific
Notified body National Standards Authority of Ireland (NSAI)
CHMP opinion PDF iconCPAR - Irvine Scientific Reproductive Media
Date of opinion 21/02/2008
Active review time (days) 176
Steps after consultation (last updated) PDF iconIrvine Scientific Reproductive Media - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical device IVF Media G5
Ancillary substance Human albumin
Manufacturer Vitrolife Sweden AB
Notified body Det Norske Veritas Certification AS
CHMP opinion PDF iconCPAR - IVF Media G5
Date of opinion 28/06/2006
Active review time (days) 174
Steps after consultation (last updated) PDF iconIVF Media G5 - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical device LifeGlobal Media
Ancillary substance Human serum albumin
Manufacturer Life Global Group LLC
Notified body BSI Group
CHMP opinion PDF iconCPAR - LifeGlobal Media
Date of opinion 26/01/2017
Active review time (days) 210
Steps after consultation (last updated)  
Name of medical device Origio
Ancillary substance Human albumin
Manufacturer Origio a/s
Notified body DGM, DS Certificering A/S
CHMP opinion PDF iconCPAR - Origio
Date of opinion 14/12/2007
Active review time (days) 195
Steps after consultation (last updated) PDF iconOrigio - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical device PureSperm Wash
Ancillary substance Human albumin solution
Manufacturer NidaCon International AB
Notified body Det Norske Veritas Certification AS
CHMP opinion PDF iconCPAR - PureSperm Wash
Date of opinion 21/02/2013
Active review time (days) 210
Steps after consultation (last updated)  
Name of medical device Surgiflo haemostatic matrix kit - Ferrosan
Ancillary substance Human thrombin
Manufacturer Ferrosan A/S
Notified body DS Certificering A/S
CHMP opinion PDF iconCPAR - Surgiflo haemostatic matrix kit - Ferrosan
Date of opinion 19/05/2011
Active review time (days) 210
Steps after consultation (last updated) PDF iconSurgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation (02/10/2017)
Name of medical device Steen solution
Ancillary substance Human albumin
Manufacturer Vitrolife Sweden AB
Notified body Det Norske Veritas Certification AS
CHMP opinion PDF iconCPAR - Steen solution
Date of opinion 13/10/2005
Active review time (days) 180
Steps after consultation (last updated) PDF iconSteen solution - Procedural steps and scientific information after initial consultation (28/07/2017)

 

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