engineered
as defined in Regulation (EC) No 1394/2007 of the European Parliament and of the Council of…, Article 2(1), point (c) (Definitions)
if they fulfil at least one of the following conditions: — the cells or tissues have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved. The manipulations listed in Annex I, in particular, shall not be considered as substantial manipulations, — the cells or tissues are not intended to be used for the same essential function or functions in the recipient as in the donor.