ACIG

22 the stage of disease come under the term ‘similar’, and should be assessed accordingly. In addition to searches for equivalent products in the literature with their associated data, results from post-market surveillance are also incorporated into clinical evaluation. Observing the market after the product has been launched is one of the manufacturer’s responsibilities, and it generates valu- able data for clinical evaluation. It includes looking at signals from the market and complaint management, but also reports in relevant databases such as that of the German Federal Institute for Drugs and Medical Devices (BfArM). The challenge for surgical instruments The MDR specifies requirements pertaining to the development, production, use and monitoring of medical devices that pose significantly greater hurdles when compared with the previous legal position. Manufacturers are facing a variety of challenges as a result of these changes, particularly those concer- ning the content of technical documentation, clinical evaluations and post- market surveillance. The scope of the new requirements will lead in many instances to a longer, stricter conformity assessment procedure for medical devices. In addition to this, there is the small number of notified authorities and the outbreak of the coronavirus pandemic – an obstacle for many com- panies. The MDR makes no distinction between whether the product is intended for a very large market or for rare diseases. Exceptions for niche applications, e.g. in the case of small patient groups, are expected to be few and far between. Any firm that wishes to bring medical devices to market must in future meet the requirements under the new MDR regulatory frame- work, and thus be able to create and present a clinical evaluation (see MDR, Annexes II and III). This equally ap- plies to the field of surgery and natu- rally concerns all medical technology ENGLISH Surgical instruments in use