What is traceability under Directive 93/42/EEC?
The information which must be supplied to the patient with the medical device is defined in Article 13 of Annex I to Directive 93/42/EEC.
It is not compulsory to mention the composition materials of a medical device on the package leaflet.
For simplicity's sake, below I'm going to paste Article 13 of Annex I to Directive 93/42/EEC.
13. Information supplied by the manufacturer
13.1. Each device must be accompanied by the information necessary for its correct and safe use, taking into account the training and knowledge of potential users, and to enable the manufacturer to be identified.
This information consists of the details given in the instruction leaflet.
Wherever possible and appropriate, the information needed to use the device safely should appear on the device itself and/or on the packaging of each unit or, where appropriate, on the commercial packaging. If it is not possible to package each unit separately, the information must appear on a leaflet accompanying one or more devices.
The packaging of each device must contain an instruction leaflet. An exception is made for Class I and IIa devices, if they can be used safely without the aid of such instructions.
a) the name or business name and address of the manufacturer. In the case of devices imported into the Community for distribution, the labelling, outer packaging or instructions for use shall also contain the name and address of the authorized representative where the manufacturer is not established in the Community;
b) information strictly necessary to identify the device and the contents of the packaging, in particular for users;
c) where appropriate, the wording "STERILE";
d) where appropriate, the batch code, preceded by the word "LOT", or the serial number;
e) where appropriate, the date until which the device should be used safely, expressed in year and month;
f) where appropriate, an indication that the device is for single use only. An indication by the manufacturer of single-use must be uniform throughout the Community;
g) in the case of a custom-made device, the words "custom-made device";
h) in the case of a device intended for clinical investigations, the words "exclusively for clinical investigations";
i) special storage and/or maintenance conditions;
j) special instructions for use;
k) warnings and/or precautions to be taken.
13.2. This information should, where appropriate, take the form of symbols. Any identifying symbol or color must conform to harmonized standards. In areas where no standards exist, symbols and colors should be described in the documentation supplied with the device.
13.3. Labelling must include the following information:
l) the year of manufacture for active devices, other than those covered by point e). This indication may be included in the batch or serial number;
m) where applicable, the sterilization method;
n) in the case of a device within the meaning of Article 1(4a), a statement to the effect that the device incorporates, as an integral part, a substance derived from human blood.
13.4. If the purpose of the device is not obvious to the user, the manufacturer must clearly state it on the label and in the instruction leaflet.
13.5. As far as reasonably possible, devices and detachable components should be identified, where appropriate in terms of batches, so as to enable any appropriate action to be taken to detect a potential risk associated with the devices and detachable components.
13.6. The instruction leaflet must include, where applicable, the following information:
a) the information referred to in section 13.3, with the exception of points d) and e);
b) the performances referred to in point 3, as well as any undesirable side effects;
c) if the device must be installed with or connected to other medical devices or equipment in order to function as intended, sufficient information on its characteristics to identify the correct devices or equipment to be used in order to obtain a safe combination;
d) all the information needed to check that the device is properly installed and can operate correctly and safely, together with details of the nature and frequency of maintenance and calibration operations required to ensure that the devices operate correctly and safely at all times;
e) where appropriate, information on how to avoid certain risks associated with the installation of the device;
f) information on the risks of reciprocal interference linked to the presence of the device during specific investigations or treatments;
g) instructions in the event of damage to the sterile packaging and, where appropriate, indication of suitable re-sterilization methods;
h) if the device is intended for re-use, information on the appropriate procedures for re-use, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization if the device is to be re-sterilized, together with any restrictions on the number of re-uses possible. Where devices supplied must be sterilized before use, the cleaning and sterilization instructions are such that, if correctly followed, the device still meets the requirements of section I. If the device is marked as single-use, information on the known characteristics and technical factors known to the manufacturer which could present a risk if the device were to be reused. If, in accordance with section 13.1, no instructions for use are required, information must be made available to the user on request;
i) details of any additional treatment or handling required before the device can be used (e.g. sterilization, final assembly, etc.);
j) in the case of devices emitting radiation for medical purposes, information on the nature, type, intensity and distribution of this radiation.
The instruction leaflet must also include information enabling medical personnel to inform the patient of contraindications and precautions to be taken. This information includes in particular :
k) precautions to be taken in the event of a change in device performance;
l) precautions to be taken with regard to exposure, under reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharges, pressure or pressure variations, acceleration, thermal sources of ignition, etc. ;
m) sufficient information on the drug(s) which the device in question is intended to administer, including any restrictions on the choice of substances to be administered;
n) precautions to be taken against any special or unusual risks associated with disposal of the device;
o) a drug or human blood derivative incorporated into the device as an integral part in accordance with point 7.4;
p) the degree of accuracy indicated for measuring devices;
q) date of publication or last revision of instructions for use.