Custom-made medical device
A custom-made medical device, commonly referred to as a custom-made device or a custom device, is a medical device designed and manufactured for the sole use of a particular patient. Examples of custom-made medical devices include auricular splints, dentures, orthodontic appliances, orthotics and prostheses.
Definition
There is no globally agreed definition, but a custom-made medical device can be broadly defined as a medical device that has been designed and manufactured in accordance with a prescription from an appropriately qualified person for the sole use of a particular patient to meet their specific needs. Mass-produced medical devices that have been adapted for specific patient requirements such as customised wheelchairs, hearing aids, and spectacle frames do not typically fall within the definition of a custom-made medical device.Definitions by jurisdiction
| Jurisdiction | Definition | Legislation |
| Australia | A medical device that: is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and is intended: to be used only in relation to a particular individual; or to be used by the health professional to meet special needs arising in the course of his or her practice. | Therapeutic Goods Regulations 2002 |
| Canada | A custom-made device, as defined in the regulations, means a medical device, other than a mass-produced medical device, that is manufactured in accordance with a HCP's written direction giving its design characteristics; differs from medical devices generally available for sale or from a dispenser; and is for the sole use of a particular patient of that professionals, or, is for use by that professional to meet special needs arising in the course of his or her practice. | Medical Devices Regulations SOR/98-282 |
| European Union | Any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices | Regulation 2017/745 |
| United Kingdom | Any device specifically made in accordance with a written prescription of a registered medical practitioner, or any other person authorised to write a prescription by virtue of their professional qualification which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual condition or need but the following devices are not custom-made devices— mass-produced devices which need to be adapted to meet the specific requirements of a professional user, and devices which are mass-produced by means of an industrial manufacturing process in accordance with the written prescriptions of any authorised person | Medical Devices Regulations 2002 |
| United States | In general The requirements of sections 360d and 360e of this title shall not apply to a device that— is created or modified to comply with the order of an individual physician or dentist ; to comply with an order described in subparagraph, necessarily deviates from an otherwise applicable performance standard under section 360d of this title or requirement under section 360e of this title; is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution; is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat; is intended to meet the special needs of such physician or dentist in the course of the professional practice of such physician or dentist ; or is intended for use by an individual patient named in such order of such physician or dentist ; is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause or of subparagraph ; and may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices. Limitations Paragraph shall apply to a device only if— such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical; production of such device under paragraph is limited to no more than 5 units per year of a particular device type, provided that such replication otherwise complies with this section; and the manufacturer of such device notifies the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device. | Federal Food, Drug, and Cosmetic Act |
Types
Depending on the jurisdiction, custom-made medical devices can be prescribed by various healthcare professionals working within numerous medical specialties such as dentists, hearing aid dispensers, ocularists/orbital prosthetists, orthotists, medical practitioners/physicians and prosthetists. Manufacturers of custom-made medical devices include anaplastologists, audiologists,clinical dental technicians/dental prosthetists/denturists, dental assistants/dental nurses, dental technicians, dentists, ocularists/orbital prosthetists, ophthalmologists, optometrists, orthopaedic shoe fitters, orthopedic technicians, orthotists and prosthetists.
| Custom-made devices | Medical specialty |
| Arch bars/wafers to facilitate orthognathic surgery | Oral and maxillofacial surgery |
| Auricular splints | Plastic surgery |
| Bruxism splints | Restorative dentistry |
| Craniofacial prostheses | Oral and maxillofacial surgery |
| Dental prostheses | Oral and maxillofacial surgery/restorative dentistry: prosthodontics |
| Dental restorations | Restorative dentistry |
| Dentofacial orthopaedic/functional appliances | Orthodontics |
| Hearing aid inserts/moulds | Audiology/otology |
| Lingual arch | Orthodontics |
| Lip bumper | Orthodontics |
| Mandibular advancement splints | Sleep medicine |
| Mouthguards | Sports dentistry |
| Ocular prostheses | Ophthalmology |
| Orthodontic retainers | Orthodontics |
| Orthopaedic footwear | Orthoses |
| Palatal expansion appliances | Orthodontics |
| Quad helix | Orthodontics |
| Speech prostheses | Speech-language pathology/speech therapy |
| Transpalatal arches | Orthodontics |
Legislative requirements
Australia
In Australia manufacturers of custom-made medical devices are exempt from registering with the Australian Register of Therapeutic Goods. Manufacturers of custom-made medical devices cannot advertise such devices directly to patients and are required to:- Notify the Therapeutic Goods Administration that they are providing custom-made medical devices.
- Comply with the ARTG exemption conditions concerning inspection and review.
- Provide appropriate documentation with devices that they manufacture and/or supply.
- Maintain records relating to the devices that they have manufactured and/or supplied in Australia for at least five years.
- Submit an annual report with details of the custom-made medical devices that they have manufactured and/or supplied to the Therapeutic Goods Administration.
Canada
European Union
Custom-made devices manufactured in the European Union are subject to Regulation 2017/745|Regulation 2017/745, which replaced and repealed Medical Devices Directive|Directive 93/42/EEC. Under the MDD, manufacturers of custom-made devices were required to follow the relevant Essential Requirements set out in Annex I and the procedure set out in Annex VIII.The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period, was expected to replace and repeal the MDD on 26 May 2020. But on 23 April 2020, Regulation 2020/561 was adopted which deferred the full implementation of the EU MDR for one year until 26 May 2021 so that efforts could be concentrated on the response to the coronavirus disease 2019 pandemic. Under the EU MDR, manufacturers of custom-made devices are required to:
- Establish, document, implement and maintain, keep up to date and continually improve a quality management system. These requirements are provided in EU MDR Article 10 and are aligned with certain clauses of ISO 13485, the International Organization for Standardization quality management system requirements for the design and manufacture of medical devices.
- Comply with the relevant General Safety and Performance Requirements set out in Annex I. These obligations are comparable with the MDD Annex I Essential Requirements but are expanded and include the requirement to establish, implement, document and maintain a risk management system, the requirements of which are in alignment with ISO 14971, the ISO standard for the application of risk management to medical devices.
- The procedure set out in Annex XIII, which is comparable with MDD Annex VIII but with some enhanced requirements.
- Review and document experience gained in the post-production phase and report serious incidents and field safety corrective actions.
- Manufacturers outside the EU who are placing medical devices on the EU market are obligated to appoint a European Authorized Representative.