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).