Next Update on EU Borderline Guidance

Shortly after the last update to Version 1.18 the European Commission now published the latest version 1.19 of the EU " MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES".


The new version gives further clarification for the following products:


  • Rugby helmet
  • Autopsy saw
  • Water filter
  • Bone void filler containing animal growth factors
  • Weight management products
  • Cryotherapy chambers

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.


With this publication our post 2017-12-07 becomes obsolete (but will be kept for reference only).