You may require this code if you intend to manufacture or supply cardiac valve prostheses.
This code outlines the design and manufacture standards of a surgical heart valve substitute intended for implantation in human hearts. This code excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices and also excludes homografts.
Please note that the Agency has advised that there are various codes for medicines, medical devices and chemicals that are amended on a regular basis. Please consult the Contact Officer for more information and to ascertain the level of compliance that may be required.