Ann: VitroGro ECM CE Mark Approval Referred to MH, page-11

re: Ann: VitroGro ECM CE Mark Approval Referr... Are we talking about the device rules in Annexe IX of Directive 93/42/EEC?

Rule 8
All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended:
- to be placed in the teeth, in which case they are in Class IIa,
- to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III,
- to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III,
- or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III.

Rule 13
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 65/65/EEC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III.