Ovogene confirms that all our donor related processes such as donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells fully comply with the highest European standards - Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004.

Does Ovogene follow all the quality requirements of the international ISO 9001 standard?

Ovogene follows all the quality requirements of international ISO 9001 standard in our daily work by implementing Standard Operation Procedures for all critical donor related steps from donor recruitment to transport of cryopreserved biological materials worldwide including traceability and witnessing for all the donor samples on every stage of its processing.

Which European IVF standards does Ovogene comply with?

We perform annual internal audits of all our processes, implement a procedure for nonconformance management and a risk management approach in all our processes and procedures. We are proud to declare that our company fully complies with European IVF standards as well as with the FDA, Health Canada, HFEA, ANVIZA, ANZICA and other requirements. We ensure compliance with the highest world IVF standards in every step of our activities.

Ovogene Local ART Regulations Compliance

HFEA regulatory compliance

  • Non-anonymous egg donors (listed in a separate catalog)
  • ISO 9001:2015 (quality management system), ISO 15189 (medical laboratories)
  • 10-family limit
  • 3-month oocyte quarantine
  • 150+ fully examined egg donors
  • Direct shipping to the UK

FDA regulatory compliance

  • FDA registered egg donor bank (Ovogene, IVMED)
  • All donors approved by an FDA certified laboratory
  • Fully examined egg donors
  • Proven fertility guaranteed
  • Guarantee packages on donor oocytes and embryos

EU-Tissue Directive 2004/23/CE compliance

  • EU Coding Platform (SEC code)
  • Anonymous / non-anonymous donors
  • Controlled family limit
  • Fully examined donors
  • Donors up to 30 years old
  • Experience in shipping to European countries
  • Egg quality guaranteed

ANVISA requirements compliance

  • 150+ fully examined egg donors
  • Donor DNA sample storage
  • Direct hand-carried shipping to diverse destinations across Brazil
  • Trusted cooperation with more than 15 ART clinics in different parts of Brazil (Rio de Janeiro, Belo Horizonte, Passo Fundo, Fortaleza, São Paulo, Brasília, etc.)
  • Local Portuguese speaking representative of Ovogene

Austrian Reproductive Medicine Act compliance (FMedG)

  • Non-anonymous egg donors
  • Donors up to 30 years old
  • 3-family limit
  • Вackup samples collection according to the Austrian Reproductive Medicine Act (FMedG) and the Austrian Tissue Safety Act
  • Fully examined egg donors
  • The child conceived via egg donation gains the right to receive information about the donor at the age of 14

Swedish ART regulatory compliance

  • Non-anonymous egg donors
  • Donors with proven fertility
  • Donors between 23 and 35 years old
  • 6-family limit
  • Fully examined egg donors (Communicable diseases: HIV I/II, HTLV I/II, hepatitis B, hepatitis C, syphilis, chlamydia, gonorrhea)
  • Genetic tests (Blood type, thalassemia, cystic fibrosis, spinal muscular atrophy (SMA), hereditary deafness (GJB2), chromosome analysis)
  • The child conceived via egg donation has the right to receive information about the donor at a mature age

Canadian ART regulatory compliance

  • Donor health control via the double testing system: screenings in our laboratory and a reliable US laboratory
  • Egg quality guaranteed
  • Transparent Guarantees and Compensation system
  • Experience in shipping to Canada

Argentine ART regulatory compliance

  • Experience in shipping to Argentina: we offer organizational support and safe hand-carried biomaterial transportation
  • Transparent Guarantees and Compensation system
  • No waiting list

Australian ART regulatory compliance

  • Assisted Reproductive Technology Act 2007 & Assisted Reproductive Technology Regulation 2009
  • RTAC Code of Practice
  • Family limits according to the state regulations (5 family limits in NSW)
  • Donors are counseled by an ANZICA certified counsellor
  • Commonwealth legislation
  • Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006
  • 2007 NHMRC ethical guidelines on the use of ART in clinical practice and research
  • ART clinic policies and procedures
  • Non-anonymous egg donors (the child conceived via egg donation has the right to receive information about the donor at a mature age)
  • Transparent Guarantees and Compensation system
  • Fully examined donors
  • No waiting list
  • Experience in shipping to Australia

Contact us

Name
Phone number
Email
Message