Borderline & Classification Manual: EU MDR & IVDR

The EU has released the first version of the Manual on Borderline and Classification, written specifically to address differences in interpretations of classification for certain non-obvious device types and the qualification as either a medical device, in-vitro diagnostic, or other. It follows the extensive work conducted by the Borderline and Classification Working Group (BCWG).

The Manual is split into the following sections:

  • Qualification of Medical Devices and borderline with:
    • IVDs.
    • Medicinal products (including advanced therapy medicinal products).
    • Biocides.
    • Substances of human origin.
    • Cosmetics.
    • Food.
    • Personal Protective Equipment (PPE).
    • General consumer products.
  • Qualification of IVDs and borderline with:
    • Medical devices.
    • General laboratory equipment.

The Manual is intended to be read in conjunction with other guidance issued by the Medical Device Coordination Group (MDCG) including MDCG 2022-5, MDCG 2021-24, MDCG 2020-16, and the Helsinki Procedure. Furthermore, the BCWG intends to update the Manual periodically, so you can expect further revisions in the future tackling important borderline cases.

The thought process used in qualifying the products is an important lesson and can be used as a resource in understanding how products should be qualified and classified under the EU Regulation.

You may access version 1 of the Manual here, but be sure to check for updated issues.