Paragraph 14 Requirements as to design and construction

(1)

The sterile pack of the device must bear, legibly and indelibly, the following particulars where appropriate in the form of generally recognised symbols—

(a)

the method of sterilisation;

(b)

an indication that enables the sterile pack to be recognised as such;

(c)

the name and address of the manufacturer;

(d)

a description of the device;

(e)

if the device is intended for clinical investigation, the words: “exclusively for clinical investigations”;

(f)

if the device is custom—made, the words “custom—made device”;

(g)

a declaration that the device is in a sterile condition;

(h)

the month and year of manufacture;

(i)

an indication of the time limit for implanting the device safely.

(2)

The sales packaging of the device must bear, legibly and indelibly, the following particulars where appropriate in the form of generally recognised symbols—

(a)

the name and address of the manufacturer;

(b)

a description of the device;

(c)

the purpose of the device;

(d)

the relevant characteristics for its use;

(e)

if the device is intended for clinical investigation, the words: “exclusively for clinical investigation”;

(f)

if the device is custom—made, the words “custom—made device”;

(g)

a declaration that the device is in a sterile condition;

(h)

the month and year of manufacture;

(i)

an indication of the time limit for implanting the device safely;

(j)

the conditions for transporting and storing the device.