Terms & Conditions concerning Hydroxylapatite coatings for Prostheses and
CE Mark regulations with respect to modification of original designs.
CE Marking Rules. [Applicable in EU]
Plasma Biotal Ltd. Issues this document to state the position held by the
company when undertaking coating work for customers. It is issued as a guide
only and is for information only. Surgeons requiring confirmation of a particular
legal position should be contact the Medical Device Agency
Plasma Biotal Ltd does not design Orthopaedic Prostheses (devices).
Plasma Biotal undertakes to place a Hydroxylapatite coating on a device for
a customer on request, subject to the negotiated contract, concerning specification,
price and delivery. See
Terms & Conditions of Sale
In placing a coating on a device for a manufacturer, it is the responsibility
of the manufacturer to obtain CE marking for that particular design of device.
In placing a coating on a device for a hospital trust or surgeon (when the
device did not originally have a HA coating), then the device is modified from
its original design. Therefore the original CE mark issued by the manufacturer
is no longer valid for the modified device.
The surgeon (or employing Trust) must be aware that they are taking the responsibility
not just for the modification but for all the aspects of the previously CE Marked
devices.
Use of such a device within the purchasing Hospital trust in the UK is not
seen by the Medical Devices Agency in the UK as placing the coated devices on
the market and therefore the devices do not need a CE mark.
The hospital trust uses the device under these circumstances as a 'Custom'
device. However the purchasing Hospital trust must NOT sell these devices to
a third party within the EU as this would be seen as marketing a product for
which it is legally necessary to obtain a CE mark.
