Medical device CE marking

New Manual Borderline and classification (vs. 1.19)

2018-04

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

It includes now:

1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
1.21. Rugby helmet
1.22. Autopsy saw
1.23. UV flow germicidal lamp
1.24. Water filter

4. BORDERLINE MEDICAL DEVICE – MEDICINAL PRODUCT
4.22. Bone void fillers containing animal growth factors
4.23. Weight management products

8. CLASSIFICATION
8.30. Whole body and partial body cryotherapy chambers

The manual can be downloaded here: library

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