ACIG

ENGLISH 21 From the Middle Ages until the early modern period, surgery was referred to in German as both “Wundarznei” (wound medicine) and “Chirurgie”, with the latter serving as the standard term to this day. Until the advent of academic surge- ry, operations were performed by barber surgeons - known in the military as “feldsher” (physician’s assistants) - who had received training in a skilled trade. The 19th century saw the beginning of the large-scale production of instruments made from steel, with Gottfried Jetter, for instance, manufacturing surgical inst- ruments in Tuttlingen from the year 1867. What started as a small workshop was rapidly expanded, quickly becoming famous for the quality of its instruments. Pro- ducing scalpels, scissors, tweezers and forceps in-house, the business would later adopt the name Aesculap and go on to define the entire region surrounding Tutt- lingen. Metal instruments continue to dominate surgical treatment in European hospitals to this day, though single-use instruments made from stainless steel as well as plastic are gaining ground. The new legislative amendments will have a considerable influence on the number of manufacturers, the type of material and the use of surgical instruments going forward. Challenges brought about by statutory requirements and changes Today, as never before, all companies involved in the medical devices industry are having to contend with the headache caused by the introduction of the new MDR. The new EU Medical Device Regulation (MDR) was adopted by the European MDR and transitional periods 27. May 2025 The last EC certificates of conformity issued during the transitionalperiodexpire 26. May 2017 MDR entered into force 26. May 2021 The transitional period ends 26. May 2022 EC certificates issued prior to 25. May 2017 expire