A custom-made medical device, commonly referred to as a custom-made device (CMD) (Canada, the European Union, the United Kingdom) or a custom device (United States), is a

medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

designed and manufactured for the sole use of a particular patient. Examples of custom-made medical devices include auricular splints,

dentures Dentures (also known as false teeth) are prosthetic devices constructed to replace missing teeth, supported by the surrounding soft and hard tissues of the oral cavity. Conventional dentures are removable ( removable partial denture or comp ...

orthodontic appliances Orthodontic technology is a specialty of dental technology that is concerned with the design and fabrication of dental appliances for the treatment of malocclusions, which may be a result of tooth irregularity, disproportionate jaw relationships ...

orthotics Orthotics () is a medical specialty that focuses on the design and application of orthoses, sometimes known as braces, calipers, or splints. An is "an externally applied device used to influence the structural and functional characteristics of ...

and

prostheses In medicine, a prosthesis (: prostheses; from ), or a prosthetic implant, is an artificial device that replaces a missing body part, which may be lost through physical trauma, disease, or a condition present at birth (congenital disorder). Prosthe ...

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

Types

Depending on the jurisdiction, custom-made medical devices can be prescribed by various

healthcare professionals A health professional, healthcare professional (HCP), or healthcare worker (sometimes abbreviated as HCW) is a provider of health care treatment and advice based on formal training and experience. The field includes those who work as a nurse, physi ...

working within numerous

medical specialties A medical specialty is a branch of medical practice that is focused on a defined group of patients, diseases, skills, or philosophy. Examples include those branches of medicine that deal exclusively with children (pediatrics), cancer ( oncology), ...

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 assistant Dental assistants are members of the dental team. They support a dental operator (such as a dentist or other treating dental auxiliary) in providing more efficient dentistry, dental treatment. ''Dental assistants'' are distinguished from other gr ...

s/ dental nurses,

dental technician A dental technician is a member of the dental team who, upon prescription from a dental clinician, constructs custom-made restorative and dental appliances. There are four major disciplines within dental technology. These are ''fixed prosthesis ...

s, dentists, ocularists/orbital prosthetists,

ophthalmologists Ophthalmology (, ) is the branch of medicine that deals with the diagnosis, treatment, and surgery of eye diseases and disorders. An ophthalmologist is a physician who undergoes subspecialty training in medical and surgical eye care. Following a ...

optometrists Optometry is the healthcare practice concerned with examining the eyes for visual defects, prescribing corrective lenses, and detecting eye abnormalities. In the United States and Canada, optometrists are those that hold a post-baccalaureate f ...

, orthopaedic shoe fitters, orthopedic technicians, orthotists and prosthetists.

Legislative requirements

Australia

In Australia manufacturers of custom-made medical devices are exempt from registering with the Australian Register of Therapeutic Goods (ARTG). Manufacturers of custom-made medical devices cannot advertise such devices directly to patients and are required to: * Notify the

Therapeutic Goods Administration The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, Disability and Ageing, the TGA regulates the safety, quality, efficacy and advertisi ...

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

In Canada, custom-made medical devices are subject to Part 2 of the Medical Devices Regulations ( SOR/98-282) under the

Food and Drugs Act The ''Food and Drugs Act'' () is an act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics (including personal cleaning products such as ...

. Serious adverse incidents with medical devices must be reported to

Health Canada Health Canada (HC; )Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary units, department of the Gove ...

within 72 hours.

European Union

Custom-made devices manufactured in the European Union are subject to Regulation (EU) 2017/745 (Medical Device Regulation U MDR, which replaced and

repeal A repeal (O.F. ''rapel'', modern ''rappel'', from ''rapeler'', ''rappeler'', revoke, ''re'' and ''appeler'', appeal) is the removal or reversal of a law. There are two basic types of repeal; a repeal with a re-enactment is used to replace the law ...

ed Directive 93/42/EEC (Medical Devices Directive DD. 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 (EU) 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 (COVID-19) 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 A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction ( ISO 9001:2015). ...

. These requirements are provided in EU MDR Article 10(9) and are aligned with certain clauses of

ISO 13485 ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive ...

, the International Organization for Standardization (ISO) 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 ISO 14971 ''Medical devices — Application of risk management to medical devices'' is a voluntary consensus standard, published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principl ...

, 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. Custom-made devices are not required to carry the

CE marking The presence of the logo on Product (business), commercial products indicates that the Manufacturing, manufacturer or importer affirms the goods' conformity with European Environment, health and safety, health, safety, and environmental prote ...

United Kingdom

In the UK manufacturers of custom-made devices are required to register with the

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are accepta ...

. Until the UK left the European Union on 31 January 2020, custom-made devices were governed by the MDD, which was given effect in UK law by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618 K MDR 2002ref name=UKMDR2002/>). Immediately after the UK's departure, the UK entered an 11-month implementation period (IP), during which EU law continued to apply. In preparation for the UK's departure from the EU, the EU MDR was essentially transposed into The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, (Statutory Instrument 2019/791 K MDR 2019, an amendment of the UK MDR 2002) and was expected to be fully implemented on exit day. The UK MDR 2002 was further amended by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (Statutory Instrument 2020/1478 K MDR 2020ref name=UKMDR2020/>), which removed the provisions of the EU MDR and substituted 'exit day' for 'IP completion day'. In Great Britain medical devices can conform to either the UK MDR 2002 (as amended) or the EU MDR until 30 June 2023.

Northern Ireland Northern Ireland ( ; ) is a Countries of the United Kingdom, part of the United Kingdom in the north-east of the island of Ireland. It has been #Descriptions, variously described as a country, province or region. Northern Ireland shares Repub ...

remains in line with EU law under the terms of the Protocol on Ireland/Northern Ireland. Custom-made devices are not required to carry the

or the UK Conformity Assessed (UKCA) marking.

United States

Custom devices are subject to requirements including labelling (

21 CFR Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy ...

Part 801), reporting (21 CFR Part 803), corrections and removals (21 CFR Part 806), registration and listing (21 CFR Part 807) and quality systems regulation (21 CFR 820). Manufacturers of custom devices are obligated to submit an annual report of custom devices to the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

but are exempt from Premarket Approval (PMA) requirements and conformance to mandatory performance standards.

References

{{reflist, 30em, refs= {{cite act , title= Therapeutic Goods (Medical Devices) Regulations 2002 (Statutory Rules No. 236, 2002) , legislature= Australia , date=14 January 2022 , article= , article-type= , index= , page= , type=Regulations , url=https://www.legislation.gov.au/Details/F2022C00061, language=English {{Cite web , date=November 2021 , title=Custom-made medical devices: Information for sponsors, health professionals & manufacturers , url=https://www.tga.gov.au/sites/default/files/custom-made-medical-devices.pdf , access-date=20 January 2022 , website=Australian Government , publisher=Therapeutic Goods Administration {{Cite book , author-link= , url=https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/medical-devices/guidance-health-care-professionals-special-access-custom-made.html , title=Guidance for Health Care Professionals on Special Access and Custom-Made Medical Devices , date=18 February 2016 , publisher=Health Canada , location=Ottawa, Ontario, Canada , page= {{cite act , type=Regulations , index= , date=7 May 1998 , article= , article-type= , title=Medical Devices Regulations SOR/98-282 , trans-title= , page= , url=https://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf , language=English {{Cite web , date=31 December 2020 , title=Custom-made devices in Great Britain , url=https://www.gov.uk/government/publications/custom-made-medical-devices/custom-made-devices-in-great-britain , access-date=20 January 2022 , website=UK Government , publisher=Medicines and Healthcare products Regulatory Agency {{cite act , title=European Parliament / European Council. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC , legislature=The European Parliament and Council of the European Union , date=5 April 2017 , article=2 , article-type=Article , index=(EU) 2017/745 , page=16 , type=Regulation , url=https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 {{cite act , title=Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12 , legislature=Council of the European Union (Medical Device Directive) , date=14 June 1993 , article=2 , article-type=Article , index= , page= , type= , url=https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF {{Cite journal , last=Green , first=James I. J. , date=15 March 2021 , title=Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices , journal=Primary Dental Journal , volume=10 , issue=1 , pages=64–88 , doi=10.1177/2050168420980980 , pmid=33722134 , s2cid=232245011 {{cite act , title=PROTOCOL ON IRELAND/NORTHERN IRELAND , legislature=United Kingdom , date=17 October 2019 , article= , article-type= , index= , page= , type= , url= https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/840230/Revised_Protocol_to_the_Withdrawal_Agreement.pdf , language=English {{cite act , title=The Medical Devices Regulations 2002 (Statutory Instrument 2002/618) , legislature=United Kingdom , date=20 May 2002 , article= , article-type= , index= , page= , type= , url= https://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf , language=English {{cite act , title=The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (Statutory Instrument 2019/791) , legislature=United Kingdom , date=1 April 2019 , article= , article-type= , index= , page= , type= , url=https://www.legislation.gov.uk/uksi/2019/791/made/data.pdf , language=English {{cite act , title=The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (Statutory Instrument 2020/1478) , legislature=United Kingdom , date=8 December 2020 , article= , article-type= , index= , page= , type= , url=https://www.legislation.gov.uk/uksi/2020/1478/pdfs/uksi_20201478_en.pdf , language=English {{cite act , title=Federal Food, Drug, and Cosmetic Act , date=11 December 2020 , article=520(b) , article-type=Section , index= , page=425–426 , type= , url=https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf {{Cite book , author-link= , url=https://www.fda.gov/media/89897/download , title=Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff , date=14 January 2014 , publisher=Federal government of the United States , location=Washington, D.C., United States , page= American football equipment Biomedical engineering Biotechnology Dental equipment Ear procedures European Union directives European Union regulations Hearing aids Implants (medicine) Lacrosse equipment Martial arts equipment Medical devices Medical technology Orthodontic appliances Orthopedic braces Plastic surgery Prosthetics Prosthodontology Protective gear Rehabilitation medicine Rehabilitation team Regulation of medical devices Restorative dentistry Rugby league equipment Rugby union equipment Sports equipment