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:
- Products intended to reduce the effects of alcohol
- Radiation shields
- D-mannose for the prevention of urinary tract infections
- Solution of 8-MOP in extracorporeal photochemotherapy
- Alum styptic pencils
- Microplate washers
The manufacturers can also use the Manual to help them better classify their medical devices. The new classification changes include:
- Tissue expanders used in the breast
- Dura guard for use with a craniotome
- Heart bypass cannulae
- Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purposes
- Mobile applications for managing pictures of moles
- 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.