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 deviceVitrolife IVF media
Ancillary substanceRecombinant human albumin solution
ManufacturerAlbumedix Ltd
Notified bodyDNV Product Assurance AS
CHMP opinion PDF icon CPAR - Vitrolife IVF media
Date of opinion25/01/2018
Active review time (days)210
Steps after consultation (last updated) PDF icon Vitrolife IVF media - Procedural steps and scientific information after initial consultation
Name of medical deviceCooperSurgical Inc ART Media
Ancillary substanceHuman albumin
ManufacturerCooper Surgical Inc
Notified bodyBSI Group The Netherlands B.V.
CHMP opinion PDF icon CPAR - CooperSurgical Inc ART Media
Date of opinion19/02/2011
Active review time (days)210
Steps after consultation (last updated) PDF icon CooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation (04/03/2021)
Name of medical deviceCOOK IVF cell culture media
Ancillary substanceHuman albumin solution
ManufacturerCatalent Indiana LLC
Notified bodyDNV GL Nemko Presafe AS
CHMP opinion PDF icon CPAR - COOK IVF cell media
Date of opinion16/02/2012
Active review time (days)180
Steps after consultation (last updated) PDF icon COOK IVF cell culture media - Procedural steps and scientific information after initial consultation (04/03/2021)
Name of medical deviceFertiPro N.V. HSA-containing ART media
Ancillary substanceHuman albumin solution
ManufacturerFertiPro N.V.
Notified bodyBSI Group The Netherlands B.V.
CHMP opinion PDF icon CPAR - FertiPro N.V. HSA-containing ART media
Date of opinion19/01/2012
Active review time (days)210
Steps after consultation (last updated) PDF icon FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation (04/03/2021)
Name of medical deviceFloseal haemostatic matrix (Floseal VH S/D)
Ancillary substanceHuman thrombin
ManufacturerBaxter AG
Notified bodyTÜV SÜD Product Service GmbH
CHMP opinion PDF icon CPAR - Floseal haemostatic matrix (Floseal VH S/D)
Date of opinion19/02/2009
Active review time (days)204
Steps after consultation (last updated) PDF icon Floseal hemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation (28/01/2022)
Name of medical deviceGems Medium Suite
Ancillary substanceHuman serum albumin
ManufacturerGenea Biomedx PTY Limited
Notified bodyBSI Group The Netherlands B.V.
CHMP opinion PDF icon CPAR - Gems Medium Suite
Date of opinion23/04/2015
Active review time (days)210
Steps after consultation (last updated) PDF icon Gems Medium Suite - Procedural steps and scientific information after initial consultation (04/03/2021)
Name of medical deviceHemoblast Bellows
Ancillary substanceHuman thrombin
ManufacturerBiom'Up France SAS
Notified bodyBSI Group The Netherlands B.V.
CHMP opinion PDF icon CPAR - Hemoblast
Date of opinion25/09/2014
Active review time (days)210
Steps after consultation (last updated)

PDF icon Hemoblast Bellows - Procedural steps and scientific information after initial consultation (15/03/2021)

Name of medical deviceIrvine Scientific Reproductive Media
Ancillary substanceHuman albumin
ManufacturerIrvine Scientific
Notified bodyNational Standards Authority of Ireland (NSAI)
CHMP opinion PDF icon CPAR - Irvine Scientific Reproductive Media
Date of opinion21/02/2008
Active review time (days)176
Steps after consultation (last updated) PDF icon Irvine Scientific Reproductive Media - Procedural steps and scientific information after initial consultation (04/03/2021)
Name of medical deviceIVF Media G5
Ancillary substanceHuman albumin
ManufacturerVitrolife Sweden AB
Notified bodyDet Norske Veritas Certification AS
CHMP opinion PDF icon CPAR - IVF Media G5
Date of opinion28/06/2006
Active review time (days)174
Steps after consultation (last updated) PDF icon IVF Media G5 - Procedural steps and scientific information after initial consultation (04/03/2021)
Name of medical deviceLifeGlobal Media
Ancillary substanceHuman serum albumin
ManufacturerLife Global Group LLC
Notified bodyBSI Group The Netherlands B.V. 
CHMP opinion PDF icon CPAR - LifeGlobal Media
Date of opinion26/01/2017
Active review time (days)210
Steps after consultation (last updated) PDF icon LifeGlobal Media - Procedural steps and scientific information after initial consultation (02/03/2021)
Name of medical deviceOrigio
Ancillary substanceHuman albumin
ManufacturerOrigio a/s
Notified bodyPresafe Denmark A/S
CHMP opinion PDF icon CPAR - Origio
Date of opinion14/12/2007
Active review time (days)195
Steps after consultation (last updated) PDF icon Origio - Procedural steps and scientific information after initial consultation (04/03/2021)
Name of medical devicePureSperm Wash
Ancillary substanceHuman albumin solution
ManufacturerNidaCon International AB
Notified bodyDet Norske Veritas Certification AS
CHMP opinion PDF icon CPAR - 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 bodyPresafe Denmark A/S
CHMP opinion PDF icon CPAR - Surgiflo haemostatic matrix kit - Ferrosan
Date of opinion19/05/2011
Active review time (days)210
Steps after consultation (last updated) PDF icon Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation (06/05/2021)
Name of medical deviceSteen solution
Ancillary substanceHuman albumin
ManufacturerXVIVO Perfusion AB
Notified bodyDet Norske Veritas Certification AS
CHMP opinion PDF icon CPAR - Steen solution
Date of opinion13/10/2005
Active review time (days)180
Steps after consultation (last updated) PDF icon Steen solution - Procedural steps and scientific information after initial consultation (04/03/2021)

 

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