News related to Regenerative Medicine, Tissue Engineering, Medical devices, Pharmaceutical industry with focus on achievements and the legal, ethical, and regulatory aspects of the field

New regulations in in vitro fertilization procedure in Poland

The new act sets strict regulations in the in vitro fertilization procedure. Destruction of embryos capable of normal development will be prohibited. Preimplantation genetic testing for selection of phenotypic traits will be also forbidden. Genetic screening will be only possible if the child would be likely to suffer from a severe genetic disease.


During infertility treatment, a maximum of six embryos will be created unless a woman is more than 35 years old or there will be other medical conditions that might decrease the chance of successful embryo development. The treatment will be carried out by “centers for infertility treatment” . The centers will have to run a reproductive cell and embryo banks to preserve the cells and embryos that have not been used for fertilization or implantation.

The secured cells and embryos might be used by the donor couple in the future or the cells and embryos could be donated to another couple. Due to the possibility of reproductive cell and embryo donation, the centers will have to maintain a registry of donors and will hand out cells or embryos for donation. The clinics willing to become centers for infertility treatment would have to obtain a suitable permission from the Ministry of Health.

The new act enforces strict regulations and might be perceived as a burden for the clinics. However we believe that, the quality of medical services will improve and errors in procedures will be minimized for patients benefit.

MedTech Europe help for Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

The “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union” …

KOMUNIKAT KOMISJI Wytyczne w sprawie przyjęcia odstępstw ogólnounijnych dotyczących wyrobów medycznych zgodnie z art. 59 rozporządzenia (UE) 2017/745

Rozporządzenie Parlamentu Europejskiego i Rady (UE) 2017/745 w sprawie wyrobów medycznych przyjęto dnia 5 kwietnia 2017 …

EMA warns against using unproven cell-based therapies

EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based …