The European Commission’s Medical Devices Expert Group have issued an updated version of the European borderline and classification manual for medical devices and in-vitro diagnostics (IVDs).
Borderline cases occur when it is not clear whether a given product is a medical device, an in-vitro diagnostic medical device, an active implantable medical device or not. Borderline cases may also apply where the product falls within the definition of a medical device but is excluded from the Directives by their scope. Classification cases are cases where a difficultly exists in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD) or where, depending on interpretation of the rules, different classifications can occur.
If there is insufficient clinical, technical and scientific data to support claims of a medical nature, the product would not meet the requirements of the MDD and thus may not be CE marked as a medical device.
The new manual, issued in its 18th version, includes all previous cases as well as clearly marked new cases. It is important to note that the latest manual will be of limited value once the European Medical Devices Regulation (MDR) and IVD Regulation (IVDR) go into effect due to different definitions and classification rules.
The document should be regarded as guidance rather than law, and may be referred to in situations such as checking product status or classification rationales. The manual represents a common understanding of the MDD and the IVD Directive between European national Competent Authorities and industry stakeholders.
To view the new European Borderline and Classification manual, please click here.