The European Commission added 12 products to its manual on “borderline and classification cases” for medical devices.
The manual provides clarifications on which products are defined as medical devices within the scope of the EU’s Medical Device Directive. For products considered medical devices, the manual describes case-by-case classifications.
The commission updates the manual regularly based on consensus among member states and other stakeholders. How a product is defined and its classification are left up to individual member states, and may vary.
It remains unclear how the interpretations may change when the EU’s new medical device and in vitro diagnostic regulations are applied in 2020 and 2022, respectively.
Half of the newly added products are not considered medical devices. These include: products intended to reduce the effect of alcohol; radiation shields; D-mannose for the prevention of urinary tract infections; solution of 8-MOP in extracorporeal photochemotherapy; microplate washers; and a mobile application for managing pictures of moles.
The other six, which are considered to be medical devices, are: Alum styptic pencils (Class IIa); tissue expanders used on the breast (Class III); dura guard for use with a craniotome (Class III); heart bypass machine (Class III); liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose (Class IIa); and a mobile application for the assessment of moles (Class I). — Ana Mulero