Implementing the EU Medical Devices Directive 93/42/EEC

Stage 9: Develop product labelling and instructions

Your Notified Body will review the way in which your device is labelled and its accompanying instructions. Remember that device classification is dependent upon the "manufacturers intended purpose". Therefore, other material, including product catalogues, may be considered.

The requirements for labelling and other information to be supplied by the manufacturer are detailed in section 13 of Annex I, "Essential Requirements".

When developing instructions and labels, it is important to consider who the ultimate user will be and what language that user speaks. There are varying requirements in each Member State.

Because of the above variances, it is strongly recommended that symbols be employed wherever possible. Such symbols are identified in EN 980:1997 "Graphical Symbols for Use in the Labelling of Medical Devices". Where a product is marked "sterile" an expiry date should also be included.

Of course, your product should bear the CE marking, as detailed in Annex XII of the Directive. Where the intervention of a Notified Body is required [Class I (Sterile/Measuring), Class IIa, Class IIb and Class III ] then the identification number of your Notified Body should accompany the `CE'.

References 93/42/EEC
 · Article 4 - Free Movement
 · Article 17 - 'CE' Marking
 · Article 18 - Wrongly affixed 'CE' Marking
 · Annex 1: 13 Information Supplied by Manufacturer
Instructions, labelling and sales material indicate the manufacturer's 'intended purpose', which directly effects device classification.
 · Annex XII - 'CE' Marking of Conformity