IVF Cube Prag - Accreditation

SUKL license for IVF CUBE

The State Institute for Drug Control (SUKL) in the Czech Republic control administrates surveillance over donation, purchase, examination, fabrication, storage and distribution of human tissues and cells aims at guarantee of their quality and safety. Part of this activity is issuance of certificate authorising the activity of tissue establishment, procurement site or diagnostic laboratories, control conduct, severe adverse events monitoring or suspect thereof, in cases of doubt whether tissues and cells governed by Act No. 296/2008 Coll., on provision of quality and safety of human tissues and cells designated for use in humans and changes to some related Acts (Act on human tissues and cells), as amended, are concerned.

These Acts came into existence as the Czech implementation of numerous EU directives. This strict regulation assures the highest quality in the field of reproductive medicine for each member of European Union.

The particular directives are:

Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.
Corrigendum to Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

You can find the SUKL license to operate for IVF CUBE here: SUKL License to Operate

Authorization to operate

The bacic license needed to run the IVF CUBE clinic is an authorization to operate a private healthcare facility. This authorization is issued by the appropriate regional authority by place of operation of the private healthcare facility, or other government bodies defined by law.

You can find the authorization to operate a private healthcare facility - IVF CUBE here: Authorization to Operate for IVF CUBE

IVF CUBE laboratory accreditation

The IVF CUBE laboratory fulfilled all conditions for obtaining accreditation by the currently highest standards CSN EN ISO 15189:2013: Medical laboratories - Particular requirements for quality and competence of laboratory processes related to human gametes and embryos.

IVF CUBE has been entitled to use the assigned acreditation mark:

You can find the Certificate of Accreditation here: Certificate of Accreditation IVF CUBE CSN EN ISO 15189:2007

Reference to the Certificate on the site of Czech Accreditation Institute: http://www.cia.cz/en/Subjekt.aspx?ID=11149