The Manual on Borderline and Classifications has recently been updated. To offer some background, this document, initially published in 2022, intends to aid manufacturers determine whether a borderline product qualifies as a medical device or an in vitro diagnostic medical device (IVD) and how it should be classified by risk.
The recent update sees the inclusion of a number of different devices including:
- Red blood cell additive solutions containing adenine, which is classified as Class III, according to Rule 14 due to the ingredient adenine, which is used in additive solutions for RBCs processing in such devices has an ancillary action to the device as medicinal substance.
- Dual action cream with menthol and capsaicin should not be qualified as a medical device as both menthol and capsaicin act upon receptors to achieve their effect, hence they act by pharmacological means.
- Lactose tablets for vaginal use should not be qualified as a medical device as the principal intended action of the product is achieved by metabolic means in the human body
- Microabrasion dental stain removers should not qualify as medical devices since the intended use is for improving the appearance of teeth and as such does not represent a medical purpose.
- Medical examination table covers should be qualified as a medical device since they are intended to be used for a specific medical purpose, namely the prevention of disease.
- Mobile sterile air system should not be qualified as a medical device as it enables an appropriate environment to perform medical interventions without having a specific medical purpose itself. The product therefore controls the environment and does not act directly in or on the human body.
The Manual serves as a consensus-based reference to help EU regulators consistently decide whether a product qualifies as a medical device or IVD and to apply the correct risk classification, reducing inconsistencies and protecting public health across the EU. We urge all manufacturers to make use of this manual if they have any doubts about qualification and classification.
More information can be found using the following link
