S.L. 427.16 Art. 8to use it safely users, on the label to use the or, where unit is not and, or in the of one for use are the label into States, the label must in which the the form of the harmonised used must considered as and the and labelling † shall apply. itself or on and the other for use. regulations and subst

Information supplied by a manufacturer 8.1. Each device must be accompanied by the information needed and properly, taking account of the training and knowledge of the potential and to identify the manufacturer. This information comprises the data and in the instructions for use. As far as practicable and appropriate, the information needed device safely and properly must be set out on the device itself and, appropriate, on the sales packaging. If individual full labelling of each practicable, the information must be set out on the packaging instructions for use supplied with one or more devices. Instructions for use must accompany or be included in the packaging or more devices. In duly justified and exceptional cases no such instructions needed for a device if it can be used properly and safely without them. The decision whether to translate the instructions for use and one or more languages of the European Union shall be left to the Member except that, for devices for self-testing, the instructions for use and include a translation into the official language(s) of the Member State device for self testing reaches its final user. 8.2. Where appropriate, the information to be supplied should take symbols. Any symbol and identification colour used must conform to standards. In areas for which no standards exist, the symbols and colour be described in the documentation supplied with the device.

8.3. In the case of devices containing a preparation which may be being dangerous, taking account of the nature and quantity of its constituents form under which they are present, relevant danger symbols * requirements of Directive 671548/EEC and Directive 88/379/EEC Where there is insufficient space to put all the information on the device its label, the relevant danger symbols shall be put on the label information required by those Directives shall be given in the instructions

*Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, administrative provisions relating to the classification, packaging and labeling of dangerous No. L 196, 16.08.67, P. 1 ). Directive as last amended by Commission Directive 97/69/EC 13.12.97, p. 19). †Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, administrative provisions of the Member States relating to the classification, packaging dangerous preparations (OJ No. L 187, 16.07.88, P. 14). Directive as last amended by Commission 96/65/EC (OJ No. L 265, 18.10.96 p. 15). provisions of the aforementioned Directives on the safety data sheet unless all relevant information as appropriate is already made available instructions for use. label must bear the following particulars which may take the form of appropriate: 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; the details strictly necessary for the user to uniquely identify the device and the contents of the packaging; where appropriate, the word "STERILE" or a statement indicating any special microbiological state or state of cleanliness; the batch code, preceded by the word "LOT", or the serial number; 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; case of devices for performance evaluation, the words "for performance evaluation only"; where appropriate, a statement indicating the in vitro use of the device; any particular storage and, or handling conditions; where applicable, any particular operating instructions; appropriate warnings and, or precautions to take; the device is intended for self-testing, that fact must be clearly stated. intended purpose of the device is not obvious to the user, the must clearly state the intended purpose in the instructions for use and, on the label.

Wherever reasonable and practicable, the devices and separate components identified, where appropriate in terms of batches, to allow all appropriate any potential risk posed by the devices and detachable components. appropriate, the instructions for use must contain the following the details referred to in point 8.4 of this section with the exception of points (d) and (e); composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well a statement, where appropriate, that the device contains other ingredients which might influence the measurement; the storage conditions and shelf life following the first opening of the primary container, together with the storage conditions and stability of working reagents; the performances referred to in point 3 of part A of this Schedule; 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 pre-treatment and, if necessary, storage conditions and instructions the preparation of the patient;

(g) a detailed description of the procedure to be followed device;

(h) the measurement procedure to be followed with the device appropriate: - the principle of the method, - the specific analytical performance characteristics sensitivity, specificity, accuracy, repeatability, limits of detection and measurement range, including needed for the control of known relevant limitations of the method and information about available reference measurement procedures and materials user, - the details of any further procedure or handling needed device can be used (for example, reconstitution, dilution, instrument checks, etc.), - the indication whether any particular training is required;

(i) the mathematical approach upon which the calculation of result is made;

(j) measures to be taken in the event of changes in performance of the device;

(k) information appropriate to users on: - internal quality control including specific validation - the traceability of the calibration of the device;

(l) the reference intervals for the quantities being determined, description of the appropriate reference population;

(m) if the device must be used in combination with or installed connected to other devices or equipment in order to operate for its intended purpose, sufficient details of its characteristics identify the correct devices or equipment to use in order and proper combination;

(n) all the information needed to verify whether the device installed and can operate correctly and safely, plus details and frequency of the maintenance and calibration needed the device operates properly and safely; information about disposal;

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

(p) the necessary instructions in the event of damage to packaging and details of appropriate methods of resterilisation decontamination;

(q) if the device is reusable, information on the appropriate allow reuse, including cleaning, disinfection, packaging resterilisation or decontamination, and any restriction on reuses;

(r) precautions to be taken as regards exposure, in reasonably environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc.; 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; 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 a device 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; date of issue or latest revision of the instructions for use.

SCHEDULE II

Based on Annex II of the Directive

OF DEVICES REFERRED TO IN REGULATIONS 7.2 AND 7.3 A Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell, reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D, Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation.

B Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd, reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies, - reagents and reagent products, including related calibrators materials, for the detection and quantification in human following congenital infections: rubella, toxoplasmosis, - reagents and reagent products, including related calibrators materials, for diagnosing the following hereditary phenylketonuria, - reagents and reagent products, including related calibrators materials, for determining the following human cytomegalovirus, chlamydia, - reagents and reagent products, including related calibrators materials, for determining the following HLA tissue groups: - reagents and reagent products, including related calibrators materials, for determining the following tumoral marker: - reagents and reagent products, including related calibrators, materials and software, designed specifically for evaluating trisomy 21, - the following device for self-diagnosis, including its related and control materials: device for the measurement of blood

SCHEDULE III Based on Annex III of the Directive

EC DECLARATION OF CONFORMITY