The working group on “Borderline and Classification” has just made available on the European Commission website the 2nd version of the Manual of qualification of borderline products and their classification under Regulations (EU) 2017/745 and (EU) 2017/746.

As a reminder, this Manual aims to rule on the qualification of certain borderline products such as oxide gas cartridges, dermal fillers, virucidal nasal sprays… that can meet the definition of:

  • Medical devices,
  • In vitro diagnostic medical devices,
  • Medicines,
  • Cosmetics,
  • Biocides…

It also specifies, as appropriate, the classification rules applicable to medical devices or in vitro diagnostic medical devices.

This new version integrates the qualification of two other products: needle counters and medical calculators.

This Manual supplements MDCG 2022-5 and MDCG 2019-11.




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