Biocide or Medical Device – the borderline cases

Determining the appropriate regulatory status of products that contain one or more biocidal active substances can potentially lead to confusion.  It is especially relevant when it is not clear whether the product is covered by the Medical Devices (MDD) or Biocide directive.

One of the biggest distinguishing issues is related to disinfectants. General disinfectants fall under the Biocides Directive 98/8/EC. However, Article 1 (2) of this Directive excludes products that are defined within the scope of Medical Devices Directive 93/42/EEC. Therefore, a certain level of confusion could potentially appear.

Mistakenly, hand disinfectants tend to be classified as medical devices. However, these products are intended for disinfecting hands and not devices, and as such will likely be covered by the Biocides Directive instead of the MDD.

Similarly, manufacturers often place insect repellents on the EU Market as medical devices by claiming that they prevent human exposure to diseases transferred by mosquitoes. However, these products are primarily intended to repel insects, such as mosquitoes and prevent insect bites. Therefore, insect repellents cannot be considered as medical devices and instead fall under the Biocides Directive 98/8/EC.

Last but not least, multipurpose disinfectants need to be carefully differentiated. Usually disinfectant products are regulated within the biocides legal framework. However, those products that are specifically intended for disinfecting medical devices fall within the scope of the Medical Devices Directive. Nevertheless, products with a multiple purpose which may be used occasionally in a medical environment are covered by the Biocides Directive instead of the Medical Devices Directive.

Obelis experts with more than 30 years of experience in CE marking services will gladly assist you in ensuring your products’ compliance – contact us today!

Ruta Petrosiute

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