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 those products that are considered medical devices, the manual also describes case-by-case determinations of their classifications.
The Commission updates the manual regularly based on consensus among member states and other stakeholders on cases in which there is uncertainty about whether a product is considered a medical device or not (borderline cases), or about how those that are medical devices are classified (classification cases). How a product is defined and the interpretation of its classification is left up to individual member states, and these may vary.