Marking of a medical device

The General Directive on the information to be included in each medical device indicates that it is information needed for the safe and proper use of the device, drafted in an intelligible manner, according to the level of training and knowledge of potential users, and the information necessary to identify the manufacturer. This information shall include the particulars given in the labelling and instructions for use. If it is not possible to pack each medical device separately, the information must appear in the leaflet accompanying one or more devices.

Regardless of where the marking is placed, it is recommended that the information be in the form of symbols. Each symbol or identification colour used must comply with harmonised standards. In cases where harmonised standards do not specify the appropriate identification symbols or colours, the symbols and colours used must be described in the documentation supplied with the medical device.

It should be borne in mind that the labelling or promotional materials, presentations and information on products must not, in particular, mislead as to the characteristics and performance of the device by:

(1) attributing to the device characteristics, functions and activities which it does not possess;

(2) creating the false impression that treatment or diagnosis by means of a device is certain to succeed, or not to inform about the expected risks associated with the use of the device in accordance with its intended use or for a longer period than anticipated;

(3) suggesting the use or characteristics of a device other than those declared in the conformity assessment.

Information to be provided in particular as part of the medical device marking:

(1) the name or business name and address of the manufacturer; in the case of a medical device imported for distribution in the Member States, the labels, outer packaging or instructions for use should also include the name and address of the authorised representative if the manufacturer is not established in a Member State;

(2) the information necessary, in particular for users, to identify the medical device and the contents of the packaging;

3. the word "STERILE" or "STERILE" if applicable;

(4) the code or number of the lot or series preceded by the word 'LOT' or 'LOT' or the serial number;

(5) an indication of the date by which the medical device may be used safely, expressed as one year and month, if applicable;

(6) an indication that the medical device is intended for single use, if applicable; this indication must be consistent across all Member States;

7) the words "custom-made product" – in the case of a custom-made product;

(8) the words "for clinical trials only" in the case of a clinical trial device;

(9) specific conditions for the storage or use of the medical device;

(10) specific operating recommendations;

(11) appropriate warnings and precautions;

(12) the year of manufacture of active medical devices not referred to in point 5; this indication may be included in the batch code, batch or series number or serial number;

(13) the sterilisation method, if applicable;

(14) information that the medical device contains a blood product, if applicable.

If the intended use of the medical device may not be obvious to users, the manufacturer shall expressly specify this use in both the marking and the instructions for use.

Where justified and possible, a medical device and components detachable from it must be identified by a batch or batch code or number in order to be able to take appropriate action to detect the potential hazard posed by those devices and their detachable components.

In addition, all products intended for use in the territory of the Republic of Poland must have markings and instructions for use in Polish or expressed by means of harmonised symbols or recognizable codes. Exceptionally, devices intended for use in the territory of the Republic of Poland supplied to professional users may have markings or instructions for use in English, with the exception of information intended for the patient which is given in Polish or expressed by means of harmonised symbols or recognisable codes.

KONDRAT Law Firm and Partners

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