Disinfectants classified as Medical Devices
Disinfectants are differentiated according to their use. Most of them are regulated by the European regulation on biocidal products, but some are only used for the disinfection of medical devices. This treatment allows the reuse of reusable medical devices that cannot be sterilised. It is in this very specific case that disinfectants are also classified as medical devices.
A medical device (MD) is defined as an instrument, apparatus, equipment or software intended to be used in humans for the diagnosis, prevention, control, treatment or mitigation of a disease or injury. MDs are regulated by European Regulation 2017/745.
A disinfectant with medical device status:
- Is specifically intended for medical devices which, in order to be used, need to be disinfected in accordance with their instruction leaflet.
- Carries CE-marking.
- Complies with the essential requirements described in the European directive on medical devices.
Products for disinfecting MDs can be of different classes and it is necessary to clearly define the class of the device prior to its marketing in order to follow the right compliance process. It can be a class IIa, IIb or even III.
EcoMundo can help you define your strategy to determine the applicable regulations for each type of product and provide support to bring you into compliance according to the requirements of each regulation (MD or biocides).
For more information on medical devices, do not hesitate to watch the replay of our webinar.
Disinfectants classified as Biocides
Disinfectants are generally classified as biocides, such as hand disinfectants effective against coronavirus.
Biocidal products are substances with general or specific action against harmful organisms, including viruses or fungi. Biocides are regulated under EU Regulation 528/2012.
A disinfectant has the status of a biocidal product when:
- It carries general or multi-use type claims (depending on the claims: bactericidal, virucidal, etc.).
- It complies with Regulation 528/2012 on the placing on the market and use of biocidal products.
Disinfectants, depending on their use, can therefore be classified as either biocidal products or medical devices. It is essential to know which category a product belongs to, and especially to think about it well before placing it on the market, in order to comply with the corresponding regulation.
Wish to know more about medical devices?
For more information, do not hesitate to contact Raïssa Abdel Kader or one of our experts!
