The manual highlights the view of BCWG regarding the qualification of products at the borderline of different categories, such as medical devices and in vitro diagnostics (IVDs), and rules for classifying medical devices and IVDs.
In the qualification sections, BCWG discusses the characteristics of borderline products and the outcome of assessing whether they are a medical device. For example, the manual cites nasal sprays with antibodies for COVID-19 as an intervention that exists at the borderline between medical devices and medicinal products. The product is not a medical device because of its mechanism of action.
The manual, the first version of which was published this month, is work in progress. Some sections still have to be completed.
RAPS.org: EU Roundup
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