EU-Borderline Products and Classification Manual updated

The Borderline Working group chaired by the EU Commission published the updated Version 1.18 of the
"MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES".

 

The document is intended to act as a guidance for the interpretation of the MDD and IVD.

The new paragraphs introduced by the update are identified by the pictogram "New" and include the products:

  • Products intended to reduce the effect 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
  • Tissue expanders used in the breast
  • Dura guard for use with craniotome
  • Heart bypass cannulae
  • Liquid nitrogene for cryopreservation of cells 
  • Mobile applications for managing pictures of moles
  • Mobile applications for the assessment of moles

 

Important notice: This document is not applicable under the MDR unless further updates will integrate the reference to the (EU) 2017/745 or (EU) 2017/746. 

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