All critical consumables used in the manufacture of therapeutic product that either come into contact with the therapeutic or influence its quality or the safety of recipients must be CE-marked medical devices (93/42/EEC).1
Where a harmonised European standard exists for such devices this is the preferred route for conformity assessment. A list of ‘reference harmonised’ EU standards is to be found at the European Commission Enterprise and Industry website.2
Labelling of critical consumables and their packaging shall comply with the EU Medical Devices Directive1 and appropriate harmonised standards.
The critical consumable or, when there is insufficient space, its individual overwrap must bear the following information:
Note: The expiry date may be expressed as: ‘Do not use after DD/MM/YY’ where DD is the day number, MM the month number and YY the year. For clarity, the expiry date will be midnight (23:59 hours) on the date shown. It is permissible to use only MM/YY; in this instance the expiry date will be midnight on the last day of the month/year shown.
The expiry date may alternatively be provided by the manufacturer on the immediate overwrap in which case the following statement must be applied to the base label: ‘Use within x days of opening the immediate overwrap’ where x is the number of days validated by the manufacturer.
Containers for intravenous solutions must in addition bear the following information on each container:
Label adhesives applied directly to the surface of a critical consumable that may come into contact with blood or tissue must be tested and approved by manufacturers in accordance with the relevant current versions from the ISO 10993 biocompatibility series of standards (or equivalent national standards). The risk of the adhesive coming into contact with blood or tissue should be established by ‘extractables’ testing (ISO 10993 – Parts 1, 17 and 18). If testing reveals an unacceptable level of migration, biocompatibility testing should be extended to interaction with blood (ISO 10993 – Part 4) and toxicological testing (ISO 10993 – Parts 3 and 5).