When a product is intended for disinfection of medical instruments and falls under legislation for medical devices, should it also have an N number? Or is a CE number sufficient?
For products subject to transitional legislation and products with European-authorised active substances, the following applies: when a product is intended for disinfection of a medical device and falls under the legislation for medical devices, but is also intended for general disinfection, this latter use is not covered by legislation for medical devices, and the Biocidal Products Regulation (BPR - Articles 89 and 93) also applies to this use.
This means that a single product can be authorised as both a medical device and a biocidal product.
Consequently, a disinfectant that is used for the disinfection of a medical device as well as for general disinfection is subject to the BPR and must therefore be authorised as both a medical device and a biocidal product.
This also means that when a product is used for disinfection of a medical device and its use is fully covered by the scope of medical device legislation, the product does not fall under the BPR. In that case, no authorisation as a biocidal product is required.