When taking in consideration the characteristics of a disinfecting product for the purpose of product classification, claims may appear to be medical. As a consequence, manufacturers may conclude that their products fall within the scope of a medical device or an accessory to a medical device.
The MDD 93/42/EEC, Annex IX, rule 15 dictates:
- All devices intended specifically to be used for disinfecting medical devices are in Class IIa. ►M5 Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.
Meaning, only products intended to disinfect medical devices will fall within the scope of the medical device directive.
By form of derogation, other disinfecting products such as, hand disinfectants or single use sterile brushes and sponges (with or without disinfectants to be used by healthcare professionals for washing and cleaning the nails, hands and/or arms before surgical procedures) are likely to be governed by other Community legislations, such as the Medicinal Directive 2001/83/EC or the Biocide Products Directive 98/8/EC.
Only a medical device or an accessory to a medical device must bear the CE marking once conformity with the essential requirements of the medical device directive, have been met. Non-EU manufacturers must also appoint a European Authorized Representative (EAR) in the European Community as a mandatory requirement.
To know more about the classification rules for medical devices, contact us