Personalized Medical Devices: Custom-made Medical Devices under Turkish Law01 June, 2020
Individualized medical device production on a commercial scale is currently possible with the development of manufacturing technologies including computer-controlled additive and subtractive manufacturing methods based on patient images and digital patient data. Personalized medical devices can be categorized as custom-made medical device, patient-matched medical device, and adaptable medical devices according to their characteristics. Custom-made medical devices have already been regulated by various jurisdictions intending to cover particular cases where mass produced commercial products are inadequate to match with individual needs. This article aims to provide an insight regarding personalized devices and points to consider for manufacturers of custom-made medical devices under the Regulation on Medical Devices which was prepared in accordance with EU Council Directive 93/42/EEC on Medical Devices (MDD).
Personalized Medical Device
International Medical Device Regulators Forum (“IMDRF”) has published Personalized Medical Devices - Regulatory Pathways (“Personalized Medical Devices”) on, a best-practice model for suitable regulatory pathways for different types of personalized medical devices, explaining growing numbers of patients are receiving individualized medical devices, to meet their particular needs, without there being adequate regulatory oversight in place. Accordingly, personalized medical devices are categorized into three groups: i) custom-made medical device, ii) patient-matched medical device and, iii) adaptable medical devices.
Custom-made medical devices are intended to cover special cases where commercially available products or alternative therapies are inadequate for meeting the needs and requirements of particular individuals. As per the Personalized Medical Devices, custom-made medical devices should at least be; i) intended for the sole use of a particular individual, ii) specifically made in accordance with a written request of an authorized healthcare professional, which gives, under their responsibility, specific design characteristics, even though the design may be developed in consultation with a manufacturer; and iii) intended to address the specific anatomo-physiological features or pathological condition of the individual for whom it is intended. Patient-matched, adaptable or mass-produced medical devices are not considered to be custom-made.
Patient-matched medical devices are i) matched to a patient’s anatomy using techniques such as scaling of the device based on anatomic references, or by using the full anatomic features from patient imaging; ii) typically produced in a batch through a process that is capable of being validated and reproduced; and iii) designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with an authorized healthcare Professional. With respect to patient-matched medical devices, a written request from an authorized healthcare professional may be present; but is not mandatory. Also, the design should remain within the validated parameters of the specified design envelope for the medical device.
Adaptable medical devices, on the other hand, are mass-produced and adapted, adjusted, assembled or shaped at the point of care, in accordance with the manufacturer’s validated instructions, to suit an individual patient’s specific anatomo-physiologic features prior to use.
Custom-made Medical Devices under the Regulation on Medical Devices
Pursuant to the Regulation on Medical Devices “custom-made device” means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which give specific design characteristics and is intended for the sole use of a particular patient, excluding mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner. Issues such as conformity assessment procedures, statement requirement concerning medical devices for special purposes, and placing on market regarding custom-made medical devices are regulated under the Regulation on Medical Devices:
Even though a custom-made medical device is manufactured to meet the specific requirements of the medical practitioner, it is still required to conform to the essential requirements set forth under the Annex I of the Regulation on Medical Devices. Accordingly, a manufacturer should consider the general requirements to ensure that the medical device will not compromise the clinical condition or the safety of patients or the safety and health of users when used under the conditions and for the intended purposes.
The manufacturer should ensure that the design and construct of the devices are in accordance with safety principles and when determining the solutions: i) eliminate or reduce risks as far as possible (inherently safe design and construction), ii) take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, iii) inform users of the residual risks due to any shortcomings of the protection measures adopted. The manufacturer should also consider the chemical, physical and biological properties, infection and microbial contamination, construction and environmental properties of the medical device, protection against radiation, requirements for medical devices connected to or equipped with an energy source and information supplied by the manufacturer including the label and instructions for use.
Statement Concerning Medical Devices for Special Purposes
In the case of custom-made devices, prior to placing each device on the market, the manufacturer shall prepare the statement concerning medical devices for special purposes referred to in Annex XIII of the Regulation on Medical Devices following the procedure referred thereunder. This statement should contain data allowing identification of the custom-made medical device; a statement that the device is intended for exclusive use by a particular patient, together with the name of the patient; the name of the medical practitioner who issued the prescription and, where applicable, the name of the clinic concerned; the particular features of the device as specified in the relevant medical prescription; and a statement that the device conforms to the essential requirements set out in Annex I of the Regulation on Medical Devices and, where applicable, indicating which essential requirements have not been fully met, together with the grounds. It is the manufacturer’s responsibility to take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with this statement. The manufacturer is also obliged to submit a list of such devices which have been put into service to the Ministry of Health (“Ministry”) pursuant to the Regulation on Medical Devices.
In addition, to allow assessment of conformity with the requirements for custom-made devices under the Regulation on Medical Devices, the manufacturer is obliged to keep available the documentation allowing an understanding of the design, manufacture and performances of the product, including the expected performances, for at least five years.
The label of a custom made medical device should at least bear the manufacturer’s name/title and address or if the medical device is imported from the European Economic Area the name/title and address of the manufacturer there, the details strictly necessary for the user to identify the device and the contents of the packaging, and the words “custom-made device”. In addition, the manufacturer should consider if other information should be provided and determine the applicable requirements set out under the Regulation on Medical Devices.
Pursuant to the Regulation on Medical Devices, medical devices considered to meet the essential requirements, except for medical devices which are custom-made or intended for clinical investigations, must bear the CE marking of conformity when they are placed on the market. However, custom-made medical devices shall not bear the CE marking provided that they meet the conditions regarding conformity assessment and the abovementioned statement concerning medical devices for special purposes referred to in Annex VIII is issued. In addition, Class IIa, IIb and III custom-made medical devices accompanied by the statement concerning medical devices for special purposes can be placed on the market and put into service without bearing the CE marking.
Registering with the Product Monitoring System
Regarding the custom-made medical devices under the scope of the Regulation on Medical Devices, a medical device registration application should be submitted through the Product Monitoring System (“ÜTS”) in order to assess registration application’s conformity with the Regulation on Medical Devices.
Pursuant to the Regulation on Medical Devices, any manufacturer including manufacturers of custom-made medical devices, who places devices on the market under his own name and have a registered place of business in Turkey shall inform the Ministry of the address of the registered place of business and the description of the devices concerned. If the manufacturer who places devices on the market under his own name does not reside in Turkey, his representative should inform the Ministry instead.
As per the announcement of The Turkish Medicines and Medical Devices Agency (TITCK) regarding custom-made medical device manufacturer’s registration applications to the ÜTS dated February 25, 2019, with the registration application, along with other documentation that may be requested, the statement concerning medical devices for special purposes, the prescription containing the patient’s name and I.D. number, visual of the final product (custom-made medical device), and information regarding the medical devices used in manufacturing (if any) should be submitted.
In conclusion, as the manufacturer is responsible to determine the applicable requirements and to ensure that the manufacturing process is in compliance with the requirements of the custom-made medical device, the manufacturer of a custom-made medical device should first ensure that all elements of the custom-made medical device definition are met. To do so, the prescription should be examined carefully, and specific design characteristics should be obtained. In addition, as advised with the Personalized Medical Devices, the manufacturer should determine the classification the device would have were it not custom-made and consider applying the equivalent regulatory requirements, according to the device classification, for example, custom-made medical devices may be subject to clinical investigation. The essential requirements and obligations regarding the statement concerning medical devices for special purposes set under the Regulation on Medical Devices should be assessed before manufacturing and conducting a risk analysis in order to determine the most appropriate methods to employ such as computational modelling and simulation methods or physical testing should also be considered.