Labeling and Instructions for Use - Medical Device Design: Innovation from Concept to Market - page 277

EC. As with all such queries, obtain guidance from the regulatory bodies before undertaking
the expense of printing!
The sooner this aspect of medical devices regulations gets harmonized the better. Luckily,
there is consensus starting to form and as soon as ISO 15223-2 (ISO, 2010) becomes live, all
labeling will become a lot easier.
11.3.6 Translation
The benefit of symbols is that they need no translation. However if you need to have a
product description, such as Giving Set , then this will need to be translated into the languages
of the countries into which you will sell. Even a modest global company can expect to
have 13 translations (English, French, German, Spanish, Japanese, etc.). Hence try to avoid
unnecessary translations as these will not only take up valuable label space but will also cost
you in translation fees. We will discuss translation protocols later.
11.3.7 Position of Labels
It is commonplace to have labels on the top and bottom of the box. However, think of the
nurse or technician who has to find the box on a stack of shelves. For them the better place for
a label is on the end of the box, which can be seen without disturbing the shelves. Once again,
your customer requirements (in the PDS) should have highlighted this issue.
11.4 Marking
Your device will need permanent marking. For safety's sake (and this is compulsory in many
countries) each component (that can be removed from said device) needs to be individually
marked. Why is this a necessity? Quite simply your device's original packaging will,
probably, be destroyed at the point of opening. Hence any record of its origin will be hard to
find. All end-users must be able to determine your device's part number and lot number at any
time of its life cycle. Hence permanent marking is important - but why for each individual
component? Things can get lost in cleaning, in unpacking. etc.…how is anyone supposed to
identify your component if it has no identity?
11.4.1 Company Identification Mark
It is very common for a company to have a recognizable trademark. In medical devices
this has another currency than simple brand awareness: instant and obvious recognition
of the manufacturer. One must always consider the potential for a device to fail. Once
your packaging has been removed and disposed of how will someone identify you as the
manufacturer? If you are famous in the field then your trademark may suffice, if not you will
need your company's registered name.