Certain active products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 on medical devices (the MDR).

Draft COMMISSION IMPLEMENTING REGULATION (EU) …/… laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose; (4 page(s), in English)

The measure reclassifies groups of active products without an intended medical purpose, by way of derogation from Annex VIII to Regulation (EU) 2017/745. The groups of products covered are laser devices, intense pulsed light devices, liposuction equipment and brain stimulation devices listed in the Annex XVI to Regulation (EU) 2017/745.