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Rules and requirements

Application Requirements

  1. ART Centres applying for good clinical practice certification are expected to comply with ESHRE Guidelines, Consensus Documents and Recommendations available through https://www.eshre.eu/Guidelines-and-Legal. Reasons should be provided if there is any deviation from these standards. Evidence should be provided to show how clinics inform patients of any deviation accordingly.

  2. Centres must have documented contingency plans with another tissue establishment to ensure safe relocation of fresh and cryopreserved gametes and embryos in case of an emergency. Centres shall have service level agreements with all third parties involved for legal, actuarial, and accountability issues.

  3. Centres must have all equipment and tests available to guarantee standardised fertility work up in both female and male.

  4. Centres must have fully documented policies and SOPs in place to cover all activities performed.

  5. Centres should monitor clinical and laboratory key performance indicators and meet internationally accepted competence and benchmark values.

  6. MAR procedures shall only be provided according to medical indications. Performing 100% ICSI, PGT-A or freeze-all in all patients is NOT considered good clinical practice. Therefore, applications from centres performing 100% ICSI, PGT-A or freeze-all will be declined. Previously certified centres who performed 100% ICSI, PGT-A or freeze-all at the time of certification, will NOT be able to renew their certificate if they have NOT changed their policy regarding this procedure.

  7. Experimental procedures that may pose a health risk to patients or offspring must NOT take place in routine clinical practice. Research projects involving patients or their biological material for clinical use must have a risk management plan and approval from the Ethical Review Board.

  8. All lead healthcare professionals (clinicians, embryologists, nurses and psychologists/counsellors) should have evidence of independently assessed training and evidence of active participation in a CPD programme.