Custom-made devices

Many small and medium-sized businesses produce custom-made medical devices that are manufactured to order, adapted to the patient’s anatomical conditions. Since these devices are technically also medical devices, the manufacturers’ obligations under the MDR also apply to the manufacturers of such devices, even despite the fact that Annex XIII of the legislation requires documentation that is different from what is laid down by the general rule. This often means a significant burden for manufacturers who, although they have been involved in the production of such devices for a long time, have not yet encountered, for instance, the introduction of a quality management system or the maintenance of the post-market follow-up system, which we run into in practice many times.