Increased requirements for custom-made products in accordance with the MDR
According to Art. 2 No. 3 MDR, a custom-made device is a device that is specially manufactured in accordance with a written prescription by a person authorized by virtue of his or her professional qualification, who independently determines the exact design and characteristics of the device intended for a single patient only, to meet exclusively that patient's individual condition and needs. However, mass-produced devices that must be adapted to meet the specific requirements of a professional user and devices that are mass-produced in industrial processes in accordance with the written instructions of an authorized person are not considered custom-made devices.
Manufacturers of custom-made devices are obliged to prepare documentation in accordance with Annex XIII MDR and to keep it available to the competent authorities (Art. 10 para. 5 in conjunction with Art. 52 para. 8 MDR). Custom-made devices are placed on the market without CE marking if all requirements are met (Art. 20 para. 1 MDR).
According to § 3 No. 3 MPDG, a written prescription required for the custom-made device is a certificate issued by an authorized person containing all the data required for the custom-made device, including the templates, models or impressions made by the authorized person and attached to the prescription for the design and characteristics of the device intended for a named person in order to meet the individual condition or individual needs of that person. It is clear from the explanatory memorandum to the law that the transmission of MRI and X-ray images alone is not sufficient to provide the data required for a written prescription. In addition, Section 9 MPDG contains special regulations for the adaptation of (CE-marked) products, which also require a written prescription and trigger special documentation obligations.
Therefore, if a custom-made product is to be manufactured, various questions of demarcation must first be clarified (series-produced product, adaptation of a CE-marked product, etc.) in order to ensure that it is a custom-made product. The patient-specific manufacture of the custom-made product, which excludes stockpiling, and the documentation of the patient-specific condition and the resulting patient-specific needs are of crucial importance. Here, close attention should be paid to the issuing of the prescription, which must contain all the necessary data and be issued by an authorized person. If the increased requirements for custom-made products are not observed in this respect, the accusation can very quickly be made that medical devices are being placed on the market illegally without a CE mark, which may constitute a criminal offence under national criminal law. Failure to comply with the procedure under Art. 52 MDR for custom-made devices is also a punishable offense (see Section 92 (3) No. 6 and Section 93 (3) No. 8 MPDG). Special care and attention is therefore required.
Status: 11.03.2020