Tag: Self-improvement

Statement of the Minister of Health

Minister of Health recalls that all activities within the scope of the “Polish Act on the collection, storage and transplantation of cells, tissues and organs” (Journal of Laws No. 169, item 1411, as amended) on the basis of only the consent of the Bioethics Committee, without the permission of the Minister of Health is violation of regulations of the Act. The law penalizes all activities conducted without the required permit.

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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 …