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

8.7. Where appropriate, the instructions for use must contain the following particulars: U.K.

(a)

the details referred to in section 8.4 with the exception of points (d) and (e);

(b)

composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the device contains other ingredients which might influence the measurement;

(c)

the storage conditions and shelf life following the first opening of the primary container, together with the storage conditions and stability of working reagents;

(d)

the performances referred to in section 3 of part A;

(e)

an indication of any special equipment required including information necessary for the identification of that special equipment for proper use;

(f)

the type of specimen to be used, any special conditions of collection, pre-treatment and, if necessary, storage conditions and instructions for the preparation of the patient;

(g)

a detailed description of the procedure to be followed in using the device;

(h)

the measurement procedure to be followed with the device including as appropriate:

• the principle of the method,

• the specific analytical performance characteristics (e.g. sensitivity, specificity, accuracy, repeatability, reproducibility, limits of detection and measurement range, including information needed for the control of known relevant interferences), limitations of the method and information about the use of available reference measurement procedures and materials by the user,

• the details of any further procedure or handling needed before the device can be used (for example, reconstitution, incubation, dilution, instrument checks, etc.),

• the indication whether any particular training is required;

(i)

the mathematical approach upon which the calculation of the analytical result is made;

(j)

measures to be taken in the event of changes in the analytical performance of the device;

(k)

information appropriate to users on:

• internal quality control including specific validation procedures,

• the traceability of the calibration of the device;

(l)

the reference intervals for the quantities being determined, including a description of the appropriate reference population;

(m)

if the device must be used in combination with or installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose, sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe and proper combination;

(n)

all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the device operates properly and safely; information about safe waste disposal;

(o)

details of any further treatment or handling needed before the device can be used (for example, sterilisation, final assembly, etc.);

(p)

the necessary instructions in the event of damage to the protective packaging and details of appropriate methods of resterilisation or decontamination;

(q)

if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and resterilisation or decontamination, and any restriction on the number of reuses;

(r)

precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc.;

(s)

precautions to be taken against any special, unusual risks related to the use or disposal of the device including special protective measures; where the device includes substances of human or animal origin, attention must be drawn to their potential infectious nature;

(t)

specifications for devices for self-testing:

• the results need to be expressed and presented in a way that is readily understood by a lay person; information needs to be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result) and on the possibility of false positive or false negative result,

• specific particulars may be omitted provided that the other information supplied by the manufacturer is sufficient to enable the user to use the device and to understand the result(s) produced by the device,

• the information provided must include a statement clearly directing that the user should not take any decision of medical relevance without first consulting his or her medical practitioner,

• the information must also specify that when the device for self-testing is used for the monitoring of an existing disease, the patient should only adapt the treatment if he has received the appropriate training to do so;

(u)

date of issue or latest revision of the instructions for use.