Directive 98/79/EC of the European Parliament and of the CouncilShow full title

8.4. The label must bear the following particulars which may take the form of symbols as appropriate: U.K.

(a)

the name or trade name and address of the manufacturer. For devices imported into the Community with a view to their distribution in the Community, the label, the outer packaging, or the instructions for use shall contain in addition the name and address of the authorised representative of the manufacturer;

(b)

the details strictly necessary for the user to uniquely identify the device and the contents of the packaging;

(c)

where appropriate, the word ‘STERILE’ or a statement indicating any special microbiological state or state of cleanliness;

(d)

the batch code, preceded by the word ‘LOT’, or the serial number;

(e)

if necessary, an indication of the date by which the device or part of it should be used, in safety, without degradation of performance, expressed as the year, the month and, where relevant, the day, in that order;

(f)

in case of devices for performance evaluation, the words ‘for performance evaluation only’;

(g)

where appropriate, a statement indicating the in vitro use of the device;

(h)

any particular storage and/or handling conditions;

(i)

where applicable, any particular operating instructions;

(j)

appropriate warnings and/or precautions to take;

(k)

if the device is intended for self-testing, that fact must be clearly stated.