CHMP opinions on consultation procedures

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This page lists the European Medicines Agency's opinions on the quality, safety, benefits and risks of ancillary substances incorporated in medical devices.

The Agency also publishes scientific assessment reports on these opinions after it has received confirmation of the granting of a Conformité Européenne (CE) mark for the device. 

The Committee for Medicinal Products for Human Use (CHMP) grants these opinions following the consultation procedures submitted to the Agency.

Medical deviceManufacturerNotified bodyAncillary substanceOpinion dateActive review time (days)
LifeGlobal Media*

Life Global Group LLC

BSI Group

Human serum albumin26/01/2017210
Gems Medium SuiteGenea Biomedx UK Ltd

British Standards Institutions (BSI)

Human Serum Albumin23/04/2015 210
Hemoblast, haemostatic agentBiom'UpBritish Standard Institute GroupHuman Thrombin25/09/2014210
PureSperm WashNidaCon International ABDet Norske Veritas Certification ASHuman Albumin Solution21/02/2013210
COOK IVF cell culture mediaWilliam Cook Australia Pty LtdDet Norske Veritas Certification ASHuman Albumin Solution16/02/2012180
FertiPro N.V. HSA-containing mediaFertiPro N.V.DEKRA CertificationHuman albumin solution19/01/2012210
Surgiflo haemostatic matrix kitFerrosan A/SDS Certificering A/SHuman thrombin19/05/2011210
Culture media for assisted reproductive procedures (COOPER)Cooper Surgical IncBSIHuman albumin19/02/2011210
Floseal haemostatic matrix (Floseal VH S/D)Baxter AGTÜV SÜD Product Service GmbHHuman thrombin19/02/2009204
Reproductive media products containing human tissues/plasmaIrvine ScientificNational Standards Authority of Ireland (NSAI)Human albumin21/02/2008176
Origio a/s HSA-containing mediaOrigio a/sDGM, DS Certificering A/SHuman albumin14/12/2007195
G5 SeriesVitrolife Sweden ABDet Norske Veritas Certification ASHuman albumin28/06/2006174
Steen solutionVitrolife Sweden ABDet Norske Veritas Certification ASHuman albumin13/10/2005180

*The publication of this document will take place when the notified body has reached a decision on the granting of the CE mark.

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