Manufacturers of medical devices come across the concept of “classification” in a variety of forms: in the development and approval of products, in the establishment of organizations and in the writing of scientific texts.

In this article you will learn

  • why poor classification jeopardizes your success,
  • How to avoid common mistakes and
  • how to form the classes so that there is clarity - the basis for effective and efficient work.
1. What classification and classification are a) Distinction between classification and classification

The task of classification is to determine classes - also called categories - and to assign elements to these classes.

Strictly speaking, a distinction is made between classification and classification:

  • classification
    Classification is the formation of classes by identifying common characteristics. It corresponds to the formation of categories and is therefore also referred to as categorization.
  • classification
    The classification is the assignment of elements to the previously determined classes based on their characteristics and the classification rules.

Colloquially, however, classification and classification are not separated and the term "classification" is used for both.

b) Examples

Medical device manufacturers must constantly classify:

  • Medical devices must be assigned classes (types) upon approval, as specified by the Universal Medical Device Nomenclature System UMDS, the European Medical Device Nomenclature EMDN or the Global Medical Devices Nomenclature GMDN.
  • The Medical Device Regulation MDR 2017/745 and the EU Regulation 2017/746 on in vitro diagnostics IVDR require medical devices to be assigned to classes I, IIa, IIb and III or A, B, C and D to select the appropriate conformity assessment procedures.
  • In risk management, manufacturers divide the probabilities and severity of damage into classes in order to quantify risks.
  • When transferring data, semantic standards such as the International Statistical Classification of Diseases and Related Health Problems ICD-10 , the Operations and Procedures Code OPS and the Anatomical Therapeutic Chemical Classification ( ATC Classification ) are necessary to achieve interoperability. These standards are hierarchical classification systems, ie taxonomies.
Example structure of the EMDN classification 2. How the quality of the classification affects a) How bad classification harms you

Two things can go wrong with classification:

  1. You don't form the right classes (classification in the narrower sense).
  2. You assign concepts to the wrong classes (classification).

Both errors can be very damaging to manufacturers, as the following examples show:

Error Consequence Classification, especially according to Annex VIII of the MDR . The MDR, the MDCG (especially 2019-11 and 2021-24) specify unclear and e.g. T. contradicting classification rules.
Similar problems exist with the British MHRA document. The rules are similar to MDCG 2019-11. Legal Conflicts . There are discussions and even legal disputes between manufacturers and authorities or notified bodies. EMDN . The EMDN is not comprehensive or unclear, for example be

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