New EU Borderline and Classification Manual on Medical Devices

The Working party on borderline and classification – including the European Commission – recently issued the new version of the Manual on borderline products, i.e. unclear whether the product is covered by the Medical Device/IVD Directive or not; and on classification of medical devices, i.e. uncertainty regarding the class of a medical device.

The updated Manual aims to give guidance  and to further harmonise views of the authorities and the manufacturers  on the following “disputed” borderline products:

  1. Products intended to reduce the effects of alcohol
  2. Radiation shields
  3. D-mannose for the prevention of urinary tract infections
  4. Solution of 8-MOP in extracorporeal photochemotherapy
  5. Alum styptic pencils
  6. Microplate washers

The manufacturers can also use the Manual to help them better classify their medical devices. The new classification changes include:

  1. Tissue expanders used in the breast
  2. Dura guard for use with a craniotome
  3. Heart bypass cannulae
  4. Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purposes
  5. Mobile applications for managing pictures of moles
  6. Mobile applications for the assessment of moles

Borderline products and classification of a medical device can be a complex process. Obelis experts  with more than 30 years of experience will gladly help manufacturers with their dedicated Borderline/Classification Service.

Ajda Mihelcic

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