If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the involvement of the notified body in those procedures shall be limited:
i gcás feistí arna gcur ar an margadh agus bail steiriúil orthu, na gnéithe den mhonarú a bhaineann le bail steiriúil a bhunú, a shlánú agus a choinneáil;