CHMP opinions on consultation procedures

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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.

CHMP opinions

Name of medical deviceCooperSurgical Inc ART Media
Ancillary substanceHuman albumin
ManufacturerCooper Surgical Inc
Notified bodyBritish Standards Institutions (BSI)
CHMP opinionCPAR - CooperSurgical Inc ART Media
Date of opinion19/02/2011
Active review time (days)210
Steps after consultation (last updated)CooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical deviceCOOK IVF cell media
Ancillary substanceHuman albumin solution
ManufacturerWilliam Cook Australia Pty Ltd
Notified bodyDet Norske Veritas Certification AS
CHMP opinionCPAR - COOK IVF cell media
Date of opinion16/02/2012
Active review time (days)180
Steps after consultation (last updated)COOK IVF cell media - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical deviceFertiPro N.V. HSA-containing ART media
Ancillary substanceHuman albumin solution
ManufacturerFertiPro N.V.
Notified bodyDEKRA Certification
CHMP opinionCPAR - FertiPro N.V. HSA-containing ART media
Date of opinion19/01/2012
Active review time (days)210
Steps after consultation (last updated)FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical deviceFloseal haemostatic matrix (Floseal VH S/D)
Ancillary substanceHuman thrombin
ManufacturerBaxter AG
Notified bodyTÜV SÜD Product Service GmbH
CHMP opinionCPAR - Floseal haemostatic matrix (Floseal VH S/D)
Date of opinion19/02/2009
Active review time (days)204
Steps after consultation (last updated)Floseal hemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical deviceGems Medium Suite
Ancillary substanceHuman serum albumin
ManufacturerGenea Biomedx UK Ltd
Notified bodyBritish Standards Institutions (BSI)
CHMP opinionCPAR - Gems Medium Suite
Date of opinion23/4/2015
Active review time (days)210
Steps after consultation (last updated)Gems Medium Suite - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical deviceHemoblast
Ancillary substanceHuman thrombin
ManufacturerBiom'Up
Notified bodyBritish Standard Institute Group
CHMP opinionCPAR - Hemoblast
Date of opinion25/9/2014
Active review time (days)210
Steps after consultation (last updated)Hemoblast - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical deviceIrvine Scientific Reproductive Media
Ancillary substanceHuman albumin
ManufacturerIrvine Scientific
Notified bodyNational Standards Authority of Ireland (NSAI)
CHMP opinionCPAR - Irvine Scientific Reproductive Media
Date of opinion21/02/2008
Active review time (days)176
Steps after consultation (last updated)Irvine Scientific Reproductive Media - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical deviceIVF Media G5
Ancillary substanceHuman albumin
ManufacturerVitrolife Sweden AB
Notified bodyDet Norske Veritas Certification AS
CHMP opinionCPAR - IVF Media G5
Date of opinion28/06/2006
Active review time (days)174
Steps after consultation (last updated)IVF Media G5 - Procedural steps and scientific information after initial consultation (28/07/2017) 
Name of medical deviceLifeGlobal Media*
Ancillary substanceHuman serum albumin
ManufacturerLife Global Group LLC
Notified bodyBSI Group
CHMP opinionEMA will publish this CPAR after the notified body confirms the granting of a CE mark for the device.
Date of opinion26/1/2017
Active review time (days)210
Steps after consultation (last updated) 
Name of medical deviceOrigio
Ancillary substanceHuman albumin
ManufacturerOrigio a/s
Notified bodyDGM, DS Certificering A/S
CHMP opinionCPAR - Origio
Date of opinion14/12/2007
Active review time (days)195
Steps after consultation (last updated)Origio - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical devicePureSperm Wash
Ancillary substanceHuman albumin solution
ManufacturerNidaCon International AB
Notified bodyDet Norske Veritas Certification AS
CHMP opinionCPAR - PureSperm Wash
Date of opinion21/02/2013
Active review time (days)210
Steps after consultation (last updated) 
Name of medical deviceSurgiflo haemostatic matrix kit - Ferrosan
Ancillary substanceHuman thrombin
ManufacturerFerrosan A/S
Notified bodyDS Certificering A/S
CHMP opinionCPAR - Surgiflo haemostatic matrix kit - Ferrosan
Date of opinion19/05/2011
Active review time (days)210
Steps after consultation (last updated)Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation (28/07/2017)
Name of medical deviceSteen solution
Ancillary substanceHuman albumin
ManufacturerVitrolife Sweden AB
Notified bodyDet Norske Veritas Certification AS
CHMP opinionCPAR - Steen solution
Date of opinion13/10/2005
Active review time (days)180
Steps after consultation (last updated)Steen solution - Procedural steps and scientific information after initial consultation (28/07/2017)

 

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