The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance dedicated to the custom-made medical devices and applicable regulatory framework. The scope of the document covers all custom-made medical devices, including the active implantable custom-made medical devices. The guidance is intended to assist the medical device manufacturers and other parties involved with achieving and sustaining compliance with the applicable rules and requirements in general, and in part of the claims to be made by the manufacturers in particular.
The MHRA provides the definition of the custom-made medical device prescribed by Article 5(1) of the Medical Devices Regulations. According to the aforementioned definition, a custom-made medical device is the one that is:
- manufactured specially in accordance with a written prescription of a registered medical practitioner, or other person authorized to write such a prescription by virtue of his professional qualification, which gives under his responsibility, specific characteristics as to its design; and
- intended for the sole use of a particular patient, but does not include a mass-produced product that comprises a medical device and medicinal product forming a single integral product that needs to be adapted to meet the specific requirements of the medical practitioner or professional user.
The authority also mentions that only medical practitioners having the necessary skills and qualifications are entitled to make prescriptions for the active implantable custom-made medical devices.
The aforementioned written prescription constitutes a letter or other similar document issued by the medical practitioner describing the requested shape of the device. The written prescription could also contain certain details of the customer (patient) that could be necessary to align the device to the particular patient`s needs. Thus, the medical practitioner who issues a written prescription is a person responsible for specifying the particular design characteristics of the custom-made medical device.
At the same time, the medical device manufacturer engaged in the production of custom-made medical devices shall achieve and sustain compliance with the applicable general requirements set forth by the Medical Devices Regulations. The MHRA additionally emphasizes that the spheres of responsibility of the medical device manufacturer and medical practitioner issuing the written prescription do not overlap. Moreover, the activity of the medical practitioner is not subject to regulation under the Medical Devices Regulations. Hence, the obligations and responsibilities of the medical device manufacturer producing a custom-made medical device should not interfere with the professional and clinical responsibilities of the medical practitioner issuing the prescription.
As it is also mentioned in the MHRA guidance, general medical devices that could or should be adapted in order to meet the needs of the particular patient and consequently, the appropriate requirements, should not be deemed as custom-made medical devices.
In order to clarify the general ideas of the custom-made medical device concept, the MHRA also provides certain examples of such products, together with the references to the main parties involved: prescriber and manufacturer.
Requirements for Custom-Made Medical Devices
Besides the general information about the custom-made medical devices and regulatory framework, the MHRA guidance also contains additional clarifications regarding the conformity assessment requirements in the context of custom-made medical devices. According to the document, the medical devices manufacturers producing custom-made medical devices are obliged to ensure compliance with the applicable requirements set forth by the appropriate Annexes of the Directives (the document refers to the EU Medical Devices Directives governing the aspects related to medical devices before the new Medical Devices Regulations entered into force).
The core aspects to be considered by the medical device manufacturer include the following ones:
- chemical, physical and biological properties of the device,
- infection and microbial contamination,
- construction and environmental properties,
- protection against radiation,
- requirements for medical devices connected to or equipped with an energy source,
- information supplied by the manufacturer, including labels.
The document also contains a detailed description of the requirements in the part of the labeling of custom-made medical devices. According to the MHRA guidance, in case the labeling of custom-made medical devices shall contain the following information:
- the name and address of the medical device manufacturer (in case of the imported medical devices – the same for the authorized representative of the foreign medical device manufacturer),
- the details the medical practitioner needs to identify the medical device and the content of the packaging (for example, it is allowed to indicate the name of the patient or prescription of the device),
- the indication that the particular product is a custom-made device (the appropriate wording).
The MHRA also mentions that all other requirements related to the information the medical device manufacturer shall provide together with the device as set forth by the relevant regulations also remain applicable.
The document outlines other important points related to custom-made medical devices, namely:
- such devices do not require CE marking, but anyway should comply with the requirements set forth by the applicable regulations,
- it is not required to engage a notified body before making a custom-made device available for the medical practitioner and patient.
Statements Concerning Custom-Made Devices
One of the most important regulatory requirements related to custom-made medical devices addresses the aspects related to the statement to be issued by the medical device manufacturer. In accordance with the risk-based classification, a custom-made medical device could be classified as either a Class I, Class IIa, Class II(b), or Class III device. In the case of Class I custom-made medical devices the requirement to provide a statement could be waived.
The medical device manufacturer shall be solely responsible for ensuring that the medical device meets any and all requirements set forth under the Medical Devices Directives, as well as the Medical Devices Regulations.
The statement to be provided by the medical device manufacturer with regard to a custom-made device shall contain the following elements:
- the information necessary to identify the device (e.g. serial/order number, description, generic name),
- a statement indicating that the device should be used only by a particular patient, while the reference to the particular patient should be made by indicating either patient`s name of the appropriate identification number),
- the name of the medical practitioner who issued a written prescription describing the specific requirements the custom-made device should meet,
- extracts from the aforementioned written prescription outlining the shape and characteristics of the medical device,
- a statement indicating that the custom-made medical device complies with any and all applicable regulatory requirements (any deviations should be justified from the safety standpoint),
- the details for the medical device manufacturer (e.i. name and address).
This statement should be also made available to the particular patient the custom-made device in question is intended for.
The MHRA also mentions that the medical device manufacturer is obliged to duly keep all the records associated with the custom-made devices produced. Such records should be made available to the regulating authority upon request. Under the general rule, the records should be kept for 5 years for general custom made device, and 15 years in case of active implantable ones.
Summarizing the information provided here above, the present MHRA guidance on custom-made medical devices describes the most critical aspects related to medical devices manufactured to meet the specific needs of a particular patient. The document also outlines the spheres of responsibility of both medical device manufacturer and medical practitioner issuing the written prescription.
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