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

Vitrolife IVF media

• Ancillary substance:

  Recombinant human albumin solution

• Manufacturer:

  Albumedix Ltd

• Notified body:

  DNV Product Assurance AS

• Date of opinion:

  25/01/2018

• Active review time (days):

  210

Consultation procedure Public Assessment Report (CPAR) - Vitrolife IVF media

Reference Number: EMA/CHMP/499319/2021Summary:

Consultation procedure Public Assessment Report (CPAR) - Consultation on an ancillary medicinal substance incorporated in a medical device

Vitrolife IVF media - Procedural steps and scientific information after initial consultation

Reference Number: EMA/CHMP/111158/2021Summary:

Procedural steps and scientific information after initial consultation

CooperSurgical Inc ART Media

• Ancillary substance:

  Human albumin

• Manufacturer:

  Cooper Surgical Inc

• Notified body:

  BSI Group The Netherlands B.V.

• Date of opinion:

  19/02/2011

• Active review time (days):

  210

Consultation on an ancillary medicinal substance incorporated in a medical device: CooperSurgical Inc ART Media

Reference Number: EMA/850703/2011

CooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation

Reference Number: EMA/760138/2022 - Rev. 3

COOK IVF cell culture media

• Ancillary substance:

  Human albumin solution

• Manufacturer:

  Catalent Indiana LLC

• Notified body:

  DNV GL Nemko Presafe AS

• Date of opinion:

  16/02/2012

• Active review time (days):

  180

Consultation on an ancillary medicinal substance incorporated in a medical device: COOK IVF cell media

Reference Number: EMA/CHMP/100577/2012

COOK IVF cell culture media - Procedural steps and scientific information after initial consultation

Reference Number: EMA/80490/2021 Rev.1

FertiPro N.V. HSA-containing ART media

• Ancillary substance:

  Human albumin solution

• Manufacturer:

  FertiPro N.V.

• Notified body:

  BSI Group The Netherlands B.V.

• Date of opinion:

  19/01/2012

• Active review time (days):

  210

Consultation on an ancillary medicinal substance incorporated in a medical device: FertiPro N.V. HSA-containing ART media

Reference Number: EMA/CHMP/66296/2012

FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation

Floseal haemostatic matrix (Floseal VH S/D)

• Ancillary substance:

  Human thrombin

• Manufacturer:

  Baxter AG

• Notified body:

  TÜV SÜD Product Service GmbH

• Date of opinion:

  19/01/2012

• Active review time (days):

  204

Consultation on an ancillary medicinal substance incorporated in a medical device: Floseal haemostatic matrix (Floseal VH S/D)

Reference Number: EMEA/CHMP/91490/2009

Floseal haemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation

Gems Medium Suite

• Ancillary substance:

  Human serum albumin

• Manufacturer:

  Genea Biomedx PTY Limited

• Notified body:

  BSI Group The Netherlands B.V.

• Date of opinion:

  23/04/2015

• Active review time (days):

  210

Consultation on an ancillary medicinal substance incorporated in a medical device: Gems Medium Suite

AdoptedReference Number: EMA/CHMP/737937/2014

Gems Medium Suite - Procedural steps and scientific information after initial consultation

Reference Number: EMA/83725/2021 Rev.1

Hemoblast Bellows

• Ancillary substance:

  Human thrombin

• Manufacturer:

  Biom'Up France SAS

• Notified body:

  BSI Group The Netherlands B.V.

• Date of opinion:

  25/09/2014

• Active review time (days):

  210

Consultation on an ancillary medicinal substance incorporated in a medical device: Hemoblast

AdoptedReference Number: EMA/66720/2015

Hemoblast Bellows - Procedural steps and scientific information after initial consultation

Reference Number: EMA/CHMP/154036/2021 Rev.1

Irvine Scientific Reproductive Media

• Ancillary substance:

  Human albumin

• Manufacturer:

  Irvine Scientific

• Notified body:

  National Standards Authority of Ireland (NSAI)

• Date of opinion:

  21/02/2008

• Active review time (days):

  176

Consultation on an ancillary medicinal substance incorporated in a medical device: Irvine Scientific Reproductive Media

Reference Number: EMEA/CHMP/52056/2008

Irvine Scientific Reproductive Media - Procedural steps and scientific information after initial consultation

Reference Number: EMA/88666/2021Rev.1

IVF Media G5

• Ancillary substance:

  Human albumin

• Manufacturer:

  Vitrolife Sweden AB

• Notified body:

  Det Norske Veritas Certification AS

• Date of opinion:

  28/06/2006

• Active review time (days):

  174

Consultation on an ancillary medicinal substance incorporated in a medical device: IVF Media G5

Reference Number: EMEA/CHMP/212141/2006

IVF Media G5 - Procedural steps and scientific information after initial consultation

Reference Number: EMA/CHMP/105435/2021 Rev.2

Kitazato ART Media

• Ancillary substance:

  Human albumin solution / gentamicin sulfate

• Manufacturer:

  Kitazato Corporation

• Notified body:

  BSI Group

• Date of opinion:

  22/06/2023

• Active review time (days):

  210

Consultation on an ancillary medicinal substance incorporated in a medical device : Kitazato ART media

Reference Number: EMA/346099/2023

LifeGlobal Media

• Ancillary substance:

  Human serum albumin

• Manufacturer:

  Life Global Group LLC

• Notified body:

  BSI Group The Netherlands B.V.

• Date of opinion:

  26/01/2017

• Active review time (days):

  210

LifeGlobal Media: Consultation procedure Public Assessment Report (CPAR)

Reference Number: EMA/CHMP/878394/2016Summary:

Consultation on an ancillary medicinal substance incorporated in a medical device

LifeGlobal Media - Procedural steps and scientific information after initial consultation

Summary:

Procedural steps and scientific information after initial consultation

Origio

• Ancillary substance:

  Human albumin

• Manufacturer:

  Origio a/s

• Notified body:

  Presafe Denmark A/S

• Date of opinion:

  14/12/2007

• Active review time (days):

  195

Consultation on an ancillary medicinal substance incorporated in a medical device: Origio

Reference Number: EMEA/CHMP/461473/2007

Origio - Procedural steps and scientific information after initial consultation

Origio A.R.T. Media

• Ancillary substance:

  Gentamicin sulfate / sargramostim (GM-CSF) / heparin sodium / insulin human

• Manufacturer:

  Cooper Surgical, Inc.

• Notified body:

  BSI Group, The Netherlands

• Date of opinion:

  20/07/2023

• Active review time (days):

  210

Consultation on an ancillary medicinal substance incorporated in a medical device: Origio A.R.T. Media

Reference Number: EMA/421977/2023

Origio A.R.T. Media - Procedural steps and scientific information after initial consultation

Reference Number: EMA/502063/2023

PureSperm Wash

• Ancillary substance:

  Human albumin solution

• Manufacturer:

  NidaCon International AB

• Notified body:

  Det Norske Veritas Certification AS

• Date of opinion:

  21/02/2013

• Active review time (days):

  210

CPAR - updated document February

Surgiflo haemostatic matrix kit - Ferrosan

• Ancillary substance:

  Human thrombin

• Manufacturer:

  Ferrosan A/S

• Notified body:

  Dnv Gl AS

• Date of opinion:

  19/05/2011

• Active review time (days):

  210

Consultation on an ancillary medicinal substance incorporated in a medical device: Surgiflo haemostatic matrix kit - Ferrosan

Reference Number: EMA/CHMP/66309/2012

Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation

Summary:

Surgiflo Haemostatic Matrix Kit - Procedural steps and scientific information after initial consultation

Steen solution

• Ancillary substance:

  Human albumin

• Manufacturer:

  XVIVO Perfusion AB

• Notified body:

  Det Norske Veritas Certification AS

• Date of opinion:

  13/10/2005

• Active review time (days):

  180

Consultation on an ancillary medicinal substance incorporated in a medical device: Steen solution

Reference Number: EMEA/CHMP/329441/2005