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 BSI Group The Netherlands B.V.
CHMP opinion PDF icon CPAR - CooperSurgical Inc ART Media
Date of opinion 19/02/2011
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 device COOK IVF cell culture media
Ancillary substance Human albumin solution
Manufacturer Catalent Indiana LLC
Notified body DNV GL Nemko Presafe AS
CHMP opinion PDF icon CPAR - COOK IVF cell media
Date of opinion 16/02/2012
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 device FertiPro N.V. HSA-containing ART media
Ancillary substance Human albumin solution
Manufacturer FertiPro N.V.
Notified body BSI Group The Netherlands B.V.
CHMP opinion PDF icon CPAR - FertiPro N.V. HSA-containing ART media
Date of opinion 19/01/2012
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 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 icon CPAR - Floseal haemostatic matrix (Floseal VH S/D)
Date of opinion 19/02/2009
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 (04/03/2021)
Name of medical device Gems Medium Suite
Ancillary substance Human serum albumin
Manufacturer Genea Biomedx PTY Limited
Notified body BSI Group The Netherlands B.V.
CHMP opinion PDF icon CPAR - Gems Medium Suite
Date of opinion 23/04/2015
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 device Hemoblast Bellows
Ancillary substance Human thrombin
Manufacturer Biom'Up France SAS
Notified body BSI Group The Netherlands B.V.
CHMP opinion PDF icon CPAR - Hemoblast
Date of opinion 25/09/2014
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 device Irvine Scientific Reproductive Media
Ancillary substance Human albumin
Manufacturer Irvine Scientific
Notified body National Standards Authority of Ireland (NSAI)
CHMP opinion PDF icon CPAR - Irvine Scientific Reproductive Media
Date of opinion 21/02/2008
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 device IVF Media G5
Ancillary substance Human albumin
Manufacturer Vitrolife Sweden AB
Notified body Det Norske Veritas Certification AS
CHMP opinion PDF icon CPAR - IVF Media G5
Date of opinion 28/06/2006
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 device LifeGlobal Media
Ancillary substance Human serum albumin
Manufacturer Life Global Group LLC
Notified body BSI Group The Netherlands B.V. 
CHMP opinion PDF icon CPAR - LifeGlobal Media
Date of opinion 26/01/2017
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 device Origio
Ancillary substance Human albumin
Manufacturer Origio a/s
Notified body Presafe Denmark A/S
CHMP opinion PDF icon CPAR - Origio
Date of opinion 14/12/2007
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 device PureSperm Wash
Ancillary substance Human albumin solution
Manufacturer NidaCon International AB
Notified body Det Norske Veritas Certification AS
CHMP opinion PDF icon CPAR - 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 Presafe Denmark A/S
CHMP opinion PDF icon CPAR - Surgiflo haemostatic matrix kit - Ferrosan
Date of opinion 19/05/2011
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 (04/03/2021)
Name of medical device Steen solution
Ancillary substance Human albumin
Manufacturer XVIVO Perfusion AB
Notified body Det Norske Veritas Certification AS
CHMP opinion PDF icon CPAR - Steen solution
Date of opinion 13/10/2005
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)

Topics

How useful was this page?

Add your rating
Average
1 rating