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 in medical devices.
CHMP opinions
| Name of medical device | Vitrolife IVF media |
|---|---|
| Ancillary substance | Recombinant human albumin solution |
| Manufacturer | Albumedix Ltd |
| Notified body | DNV Product Assurance AS |
| CHMP opinion | Consultation procedure Public Assessment Report (CPAR) - Vitrolife IVF media |
| Date of opinion | 25/01/2018 |
| Active review time (days) | 210 |
| Steps after consultation (last updated) | Vitrolife IVF media - Procedural steps and scientific information after initial consultation |
| 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 | Consultation on an ancillary medicinal substance incorporated in a medical device: CooperSurgical Inc ART Media |
| Date of opinion | 19/02/2011 |
| Active review time (days) | 210 |
| Steps after consultation (last updated) | CooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation (06/09/2023) |
| 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 | Consultation on an ancillary medicinal substance incorporated in a medical device: COOK IVF cell media |
| Date of opinion | 16/02/2012 |
| Active review time (days) | 180 |
| Steps after consultation (last updated) | 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 | Consultation on an ancillary medicinal substance incorporated in a medical device: FertiPro N.V. HSA-containing ART media |
| Date of opinion | 19/01/2012 |
| 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 (25/03/2024) |
| 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 | Consultation on an ancillary medicinal substance incorporated in a medical device: Floseal haemostatic matrix (Floseal VH S/D) |
| Date of opinion | 19/02/2009 |
| Active review time (days) | 204 |
| Steps after consultation (last updated) | Floseal haemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation (22/11/2023) |
| 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 | Consultation on an ancillary medicinal substance incorporated in a medical device: Gems Medium Suite |
| Date of opinion | 23/04/2015 |
| Active review time (days) | 210 |
| Steps after consultation (last updated) | 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 | Consultation on an ancillary medicinal substance incorporated in a medical device: Hemoblast |
| Date of opinion | 25/09/2014 |
| Active review time (days) | 210 |
| Steps after consultation (last updated) | 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 | Consultation on an ancillary medicinal substance incorporated in a medical device: Irvine Scientific Reproductive Media |
| Date of opinion | 21/02/2008 |
| Active review time (days) | 176 |
| Steps after consultation (last updated) | 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 | Consultation on an ancillary medicinal substance incorporated in a medical device: IVF Media G5 |
| Date of opinion | 28/06/2006 |
| Active review time (days) | 174 |
| Steps after consultation (last updated) | IVF Media G5 - Procedural steps and scientific information after initial consultation (04/04/2023) |
| Name of medical device | Kitazato ART Media |
|---|---|
| Ancillary substance | Human albumin solution / gentamicin sulfate |
| Manufacturer | Kitazato Corporation |
| Notified body | BSI Group |
| CHMP opinion | Consultation on an ancillary medicinal substance incorporated in a medical device : Kitazato ART media |
| Date of opinion | 22/06/2023 |
| Active review time (days) | 210 |
| Steps after consultation (last updated) |
| 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 | LifeGlobal Media: Consultation procedure Public Assessment Report (CPAR) |
| Date of opinion | 26/01/2017 |
| Active review time (days) | 210 |
| Steps after consultation (last updated) | LifeGlobal Media - Procedural steps and scientific information after initial consultation (25/08/2023) |
| Name of medical device | Origio |
|---|---|
| Ancillary substance | Human albumin |
| Manufacturer | Origio a/s |
| Notified body | Presafe Denmark A/S |
| CHMP opinion | Consultation on an ancillary medicinal substance incorporated in a medical device: Origio |
| Date of opinion | 14/12/2007 |
| Active review time (days) | 195 |
| Steps after consultation (last updated) | Origio - Procedural steps and scientific information after initial consultation (06/09/2023) |
| Name of medical device | 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 |
| CHMP opinion | Consultation on an ancillary medicinal substance incorporated in a medical device: Origio A.R.T. Media |
| Date of opinion | 20/07/2023 |
| Active review time (days) | 210 |
| Steps after consultation (last updated) | (09/11/2023) |
| Name of medical device | PureSperm Wash |
|---|---|
| Ancillary substance | Human albumin solution |
| Manufacturer | NidaCon International AB |
| Notified body | Det Norske Veritas Certification AS |
| CHMP opinion | CPAR - updated document February |
| 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 | Consultation on an ancillary medicinal substance incorporated in a medical device: Surgiflo haemostatic matrix kit - Ferrosan |
| Date of opinion | 19/05/2011 |
| Active review time (days) | 210 |
| Steps after consultation (last updated) | Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation (09/12/2022) |
| Name of medical device | Steen solution |
|---|---|
| Ancillary substance | Human albumin |
| Manufacturer | XVIVO Perfusion AB |
| Notified body | Det Norske Veritas Certification AS |
| CHMP opinion | Consultation on an ancillary medicinal substance incorporated in a medical device: Steen solution |
| Date of opinion | 13/10/2005 |
| Active review time (days) | 180 |
| Steps after consultation (last updated) | Steen solution - Procedural steps and scientific information after initial consultation (04/03/2021) |