2017-12

The European Commission has updated its manual on borderline and classification.

It includes now:

1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
1.19. Products intended to reduce the effect of alcohol
1.20. Radiation shields

4. BORDERLINE MEDICAL DEVICE – MEDICINAL PRODUCT
4.20. D-mannose for the prevention of urinary tract infections
4.21. Solution of 8-MOP in extracorporeal photochemotherapy

6. BORDERLINE MEDICAL DEVICE –COSMETIC PRODUCTS
6.2. Alum styptic pencils

7. ACCESSORY TO A MEDICAL DEVICE OR AN IN-VITRO DIAGNOSTIC MEDICAL DEVICE
7.5. Microplate washers

8. CLASSIFICATION
8.26. Tissue expanders used in the breast
8.27. Dura guard for use with a craniotome
8.28. Heart bypass cannulae
8.29. Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose

9. SOFTWARE AND MOBILE APPLICATIONS
9.7. Mobile application for managing pictures of moles
9.8. Mobile application for the assessment of moles

The manual can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en