Custom-made devicesThese guidelines aim to help manufacturers understand compliance requirements for themanufacture of custom-made active implantable medical device or custom-made medical device.As defined by the Medical Devices Regulations 5 (1): manufactured specifically in accordance with a written prescription of a registered medicalpractitioner, or other person authorised to write such a prescription by virtue of hisprofessional qualification, which gives under his responsibility, specific characteristics as toits design; and intended for the sole use of a particular patient,but does not include a mass-produced product which comprises a medical device and medicinalproduct forming a single integral product which needs to be adapted to meet the specificrequirements of the medical practitioner or professional user;Note as far as active implantable medical devices are concerned the requirement is that only amedical specialist may write the prescription. This is defined in the Regulations as ‘a registeredmedical practitioner as, or is undergoing training intended to lead to qualifications, a specialist’.Examples of professional users:Ophthalmologist, optometrist, orbital prosthetist, ocularist, audiology technicians, orthotist, dentist,hearing aid dispenser, orthopaedic shoe fitter.A written prescription may take the form of a letter from a qualified person or a moulded impressionof the shape of the required device together with the order specifying customer details, and arequest to ‘make as pattern’.It is the qualified person who is responsible for specifying the particular design characteristics of theproduct.The manufacturer of a custom-made device must meet the particular requirements of the MedicalDevices Regulations which relate to custom-made devices. These requirements are not intended tointerfere in any way with the professional and clinical responsibilities of the prescriber. The activitiescarried out by the healthcare professional in supplying or fitting a custom-made device (e.g.preparation, impression taking, prescribing, final fitting and any adaptation), are not considered tofall within the scope of the Medical Devices Regulations.Note that mass-produced devices, which need to be adapted to meet the specific requirements of ahealthcare professional (and which are supplied for the sole use of a particular patient),are not considered to be custom-made devices (e.g. contact lenses and stock footwear).ExamplesThe table below gives examples of products that might be considered as custom-made. This is forguidance only and must not be considered as an exhaustive list: DevicePrescriberManufacturerCommentDental appliancesDentistDentallaboratoriesPrescribedophthalmic specialistOphthalmologistOptometristDispensing optician(in part)Glazing shopCustom-madedevice only if lensesor frames are notmass produced.Otherwise refer toRegulation 11Artificial eyes /cosmetic shellsOcularist / orbitalprosthetistOcularist or oculartechnicianPatient-specificMaxillofacialprosthesisMedical consultantor prosthetistProsthetistPatient-specificHearing aid inserts /mouldsMedical consultantor audiologytechnician orhearing aiddispenserInsert makerPatient-specificIn-the-ear aidsMedical consultantor audiologytechnician orhearing aiddispenserAid manufacturerPatient-specificOrthopaedic footwearOrthotist or shoefitterShoemakerPatient-specificJoint replacementimplants(designed for aOrthopaedicsurgeonImplantmanufacturerNo two implantsalike but some partsthe same. Basic DevicePrescriberManufacturerCommentspecific individual)principle of functionthe same.Prosthetics andorthoticsRehabilitationconsultant ororthopaedicconsultantAlso private sectorprosthetists andorthotistsProsthetic andorthotic servicecompanies andmanufacturers orthe NHSSeeMHRA’s Guidancefor manufacturers ofprosthetic andorthotic devices. Conformity assessment requirementsManufacturers of custom-made devices must follow the requirements specified in the relevantAnnexes of the Directives which apply to them. Although a custom-made device is manufactured tothe prescribed requirements of the healthcare professional, if it is to be fit for its intended purpose,it must meet all the relevant essential requirements of the directives. The manufacturer shouldconsider whether the following are relevant. 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.As a minimum requirement the labels on a custom-made device must include: the name or trade name and address of the manufacturer or, for devices imported into theEuropean Economic Area (EEA), the name and address of a representative based there the details strictly necessary for the healthcare professional to identify the device and thecontents of the packaging (e.g. patient name/description of device) the words ‘custom-made device’.The manufacturer must also review the requirements regarding other information that is to besupplied with the device and determine what is appropriate for their products.CE markingThe Directives stipulate that custom-made devices and custom-made active implantable medicaldevices are not required to be CE marked when they are first placed on the market and/or put intoservice. However, they must meet the relevant provisions of the Directives that apply to them. Inaddition, manufacturers of custom-made devices do not require the intervention of a notified body.Statement concerning custom-made devicesThe manufacturer of a custom-made device must comply with the relevant Annex of the Directivewhich contains provisions relating to the drawing up of a statement containing the informationdetailed below and the keeping of documentation relating to the device.If the custom-made device in question would have been classified as either a class IIa, class II(b) orclass III device, within the definition of a medical device or is an active implantable medical devicethen that device must be accompanied by the statement referred to in the relevant Annex to theDirective. It should be noted that the statement does not need to be provided with a custom-madedevice which has been classified as class I.It is the responsibility of the manufacturer of the device to review all the requirements of theDirective and Medical Devices Regulations against their procedures. This statement must include: data allowing identification of the device in question, i.e. description, serial number, ordernumber, generic name a statement that the device is intended for exclusive use by a particular patient, togetherwith the name of the patient (this may be an identification number if patient confidentialityneeds to be maintained, provided it can be traced through records to the named patient) the name of the qualified person, medical practitioner or other authorised person whomade out the prescription and, where applicable, their place of work the particular features of the device as specified in the relevant prescription, i.e. the writtenprescription with its special features extracted to define the particular device a statement that the device in question conforms to all the relevant essential requirementsset out in Annex I and, where it does not, the grounds for believing it is safe for use the name and address of the manufacturer.Additionally, the manufacturer must: retain and, upon request, make documentation available to the Competent Authority,allowing an understanding of the design, manufacture and performances of the product –including the expected performances – so as to allow assessment of conformity with therequirements of the Regulations. The documentation for all active implantable medicaldevices shall be kept for a period of at least 15 years from the date of manufacture of thelast product. For all other medical devices the period is at least five years and in the case ofimplantable devices at least 15 years make the statement available to the named patient for whom the device has beenmanufactured.Legislative changes for statements concerning custom-made deviceThrough an amendment to Article 2.3 of Directive 2007/47/EC a requirement was introduced thatthe ‘statement’ detailed in Article 11.6 and Annex VIII of Directive 93/42/EC and Article 9(2) andAnnex 6 of Directive 90/85 should be available to the named patient for whom the device has beenmanufactured. Previously, responsibility rested purely with the manufacturer of the custom-madedevice to provide a copy of the statement to the prescriber of the device. The amendment extendsthis duty by requiring that the statement is available to the patient. Whilst the technical documentissued with the device should indicate if the manufacturer operates from more than one site, thisneed not be included in the statement.We have examples of how each sector of custom-made medical devices has dealt with thisrequirement.The Regulations, implementing Directive 2007/47/EC into UK law, simply require that patients aremade aware that they can request a statement and that it should be made available on request. Itdoes not go into detail about how this will be achieved. This was left to member states to determineas a matter of implementation policy according to national systems for making custom-made devicesavailable to patients.During the period of negotiations the MHRA invited all stakeholder representatives affected by thechanges to attend discussions. This was then followed up by visits to manufacturers across thecustom-made field during the consultation period to explore any practical problems which mightarise.The MHRA then held discussions with representatives from the different fields of custom-madedevices to gain an appreciation of the different ways each of these sectors of the industry would beable to implement the changes.Post-market surveillance, corrective action and vigilance procedureManufacturers of custom-made devices are required to review and document experience gained inthe post-production phase and to set up a post-market vigilance system of reporting to authorities.Specifically, manufacturers need to report any incidents resulting from the constituents or design ofthe device if they pose a serious risk to public health, or the manufacturer initiates a field safetycorrective action (e.g. a recall).Note: Ordinary return of devices to manufacturers for adjustment or fitting would not need to bereported.More detailed guidance on vigilance is available in the vigilance and adverse incidents section.RegistrationA manufacturer of custom-made devices or their authorised representative must register with thecompetent authority of the member state in which they have registered the business. Registrationwill include a description of the devices concerned and the business address. This requirementapplies to both general medical devices and active implantable medical devices. More detailedguidance on registration is available in the registration of medical devices section.
