Published on October 30, 2018 by the European Commission, the latest version of the “Manual on borderline and classification in the community regulatory framework for Medical Devices” shows through six new examples/cases how to interpret the definition of a medical device and how to apply the classification rules for borderline devices.

The manual applies in the following cases:

  • when it is not clear from the beginning whether a product is a medical device (MD), an in vitro diagnostic medical device (IVD), an active implantable medical device (AIMD) or not;
  • when the product falls within the definition of medical device, but it is excluded from the Directives for their scope;
  • when it is difficult to uniformly apply the classification rules established in the MDD;
  • when there are claims of medical nature that cannot be substantiated by technical, clinical or scientific data.

The manual therefore offers support to determine the type of device and the risk class.

While some examples in the current Manual on borderline and classification for Medical Devices classification will remain valid under the MDR, a case-by-case approach is crucial, especially for IVDs whose classification has undergone major changes.

The current version (1.20) is the second update undergone by the manual in 2018 and it replaces the version published in April.