1 Amendments of Marco CAMPOMENOSI related to 2021/2013(INI)
Amendment 569 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Emphasises that the term medical device means any instrument, device, item of equipment, software package, implant, reagent, material or other article intended by the manufacturer for use on human beings. If the medical device is to be used alone or in combination with other substances, the Commission is asked to refer to rule 21 in Annex VIII to Regulation 745/2017 on the classification of medical devices;