What is MDR Section 7.3, Rule 16?
MDR Section 7.3, Rule 16 is a part of the MDR that explains how medical devices used to disinfect other medical tools are classified. It tells us what kinds of rules these devices must follow to make sure they are safe and work properly.
How are UV-C Disinfection Devices Classified?
UV-C devices use special light to disinfect medical equipment. These devices are usually classified as Class IIa under the MDR.
This means UV-C devices are considered tobe medium-risk. They need to go through very rigid audits by Notified Bodies (called a conformity assessment) to make sure they are safe and perform the way they should.
Explanation from the European Commission on wording of "Solutions"
A key aspect of Rule 16 is the distinction between equipment like UV-C devices and "disinfecting solutions". According to a clarification from the European Commission (see below),the term "disinfecting solutions" in Rule 16 refers not to physical devices but to "a homogeneous mixture of one or more solutes dissolved ina solvent."
This means that when Rule 16 mentions solutions, it's talking about chemical mixtures used for chemical disinfection, not the equipment like UV-C devices.
This distinction is important because it helps clarify why UV-C devices are typically classified as Class IIa. They are equipment, not chemical mixtures, and thus they are regulated based on the specific risks associated with the physical nature and function of the device.
Why Is Correct Classification Important?
The correct classification of UV-C disinfection devices ensures that they are subject to appropriate regulatory oversight. Class IIa devices, like UV-C disinfectors, undergo a comprehensive conformity assessment that includes checks by Notified Bodies. This ensures that they are safe and effective for use in healthcare settings.
Classifying UV-C devices correctly under Rule 16 also helps prevent confusion among manufacturers and users. It clarifies that these devices should not be confused with chemical disinfectants, which might fall under a different classification due to their different risks and uses.
In Summary
In simple terms, MDR Section 7.3, Rule 16 classifies UV-C disinfection devices as Class IIa medical devices. This means they are considered medium-risk and need to be checked carefully to make sure they’re safe. The European Commission clarified (see below a screenshot) that when Rule 16 talks about “disinfecting solutions,” it’s not referring to a piece of equipment but to chemicals disinfectants liquids.
See below an email from the European Union that explains the term “disinfection solutions”:
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