170:
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—(a) mass-produced devices which need to be adapted to meet the specific requirements of a professional user, and (b) devices which are mass-produced by means of an industrial manufacturing process in accordance with the written prescriptions of any authorised person
156:
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
783:
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 ), an amendment of the UK MDR 2002) and was expected to be fully implemented on exit day. The UK MDR 2002 was
103:
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.
705:
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
169:
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
155:
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
143:
A custom-made device, as defined in the regulations, means a medical device, other than a mass-produced medical device, that (a) is manufactured in accordance with a HCP's written direction giving its design characteristics; (b) differs from medical devices generally available for sale or from a
131:
A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health
924:
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
637:
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:
729:
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
198:(E)(i) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated); or
775:
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 ). Immediately after the UK's departure, the UK entered an 11-month
186:(A) is created or modified to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing);
104:
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.
784:
further amended by The
Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (Statutory Instrument 2020/1478 ), which removed the provisions of the EU MDR and substituted 'exit day' for 'IP completion day'.
189:(B) to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under section 360d of this title or requirement under section 360e of this title;
904:
219:(B) production of such device under paragraph (1) 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
204:(F) is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause (i) or (ii) of subparagraph (E); and
144:
dispenser; and (c) 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.
1121:
192:(C) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;
768:
702:. 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.
723:
216:(A) such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;
207:(G) may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices.
658:
Submit an annual report with details of the custom-made medical devices that they have manufactured and/or supplied to the
Therapeutic Goods Administration.
815:
222:(C) 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.
1044:
Green, James I. J. (15 March 2021). "Medical Device
Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices".
201:(ii) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated);
455:
1264:
975:
1159:
845:
226:
1189:
1184:
748:
744:
Review and document experience gained in the post-production phase and report serious incidents and field safety corrective actions.
1254:
668:
643:
195:(D) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;
1274:
1224:
1209:
1164:
1279:
1269:
411:
386:
350:
1030:
927:(Regulation (EU) 2017/745, Article 2). The European Parliament and Council of the European Union. 5 April 2017. p. 16.
851:
655:
Maintain records relating to the devices that they have manufactured and/or supplied in
Australia for at least five years.
520:
1259:
1199:
827:
1219:
1204:
787:
In Great
Britain medical devices can conform to either the UK MDR 2002 (as amended) or the EU MDR until 30 June 2023.
777:
75:
designed and manufactured for the sole use of a particular patient. Examples of custom-made medical devices include
1229:
1284:
1244:
1174:
823:
792:
741:
The procedure set out in Annex XIII, which is comparable with MDD Annex VIII but with some enhanced requirements.
715:
699:
607:
578:
401:
826:(21 CFR 820). Manufacturers of custom devices are obligated to submit an annual report of custom devices to the
1249:
1234:
1214:
1031:
Council Directive 93/42/EEC of 14 June 1993 [1] concerning medical devices, OJ No L 169/1 of 1993-07-12
819:
692:
676:
159:
29:
830:
but are exempt from Premarket Approval (PMA) requirements and conformance to mandatory performance standards.
822:(21 CFR Part 803), corrections and removals (21 CFR Part 806), registration and listing (21 CFR Part 807) and
1001:
1179:
602:
554:
381:
288:
923:
1169:
1104:
84:
941:
747:
Manufacturers outside the EU who are placing medical devices on the EU market are obligated to appoint a
1194:
448:
415:
374:
1239:
463:
345:
244:
240:
459:
958:
718:. These requirements are provided in EU MDR Article 10(9) and are aligned with certain clauses of
1069:
1002:"Custom-made medical devices: Information for sponsors, health professionals & manufacturers"
672:
667:
In Canada, custom-made medical devices are subject to Part 2 of the Medical Devices Regulations (
438:
434:
426:
1105:
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (Statutory Instrument 2020/1478)
1088:
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (Statutory Instrument 2019/791)
1061:
707:
542:
467:
442:
430:
405:
397:
393:
341:
334:
296:
292:
256:
248:
1087:
1143:. Washington, D.C., United States: Federal government of the United States. 14 January 2014.
1053:
788:
357:
284:
76:
183:
The requirements of sections 360d and 360e of this title shall not apply to a device that—
731:
362:
726:
quality management system requirements for the design and manufacture of medical devices.
906:
Guidance for Health Care Professionals on Special Access and Custom-Made Medical Devices
839:
714:
Establish, document, implement and maintain, keep up to date and continually improve a
525:
419:
329:
72:
1153:
1140:
Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff
1073:
887:
870:
680:
547:
300:
272:
1033:(Article 2). Council of the European Union (Medical Device Directive). 14 June 1993.
871:
Therapeutic Goods (Medical Devices) Regulations 2002 (Statutory Rules No. 236, 2002)
706:
year until 26 May 2021 so that efforts could be concentrated on the response to the
803:
652:
Provide appropriate documentation with devices that they manufacture and/or supply.
619:
614:
595:
583:
559:
513:
501:
496:
473:
312:
308:
115:
767:
In the UK manufacturers of custom-made devices are required to register with the
132:
professional to meet special needs arising in the course of his or her practice.
35:
480:
320:
268:
252:
799:
756:
590:
532:
508:
92:
1057:
738:, the ISO standard for the application of risk management to medical devices.
735:
719:
571:
485:
316:
304:
280:
276:
264:
260:
88:
45:
1138:
1065:
649:
Comply with the ARTG exemption conditions concerning inspection and review.
710:. Under the EU MDR, manufacturers of custom-made devices are required to:
80:
982:. Medicines and Healthcare products Regulatory Agency. 31 December 2020
489:
369:
691:
Custom-made devices manufactured in the European Union are subject to
772:
696:
942:
The Medical Devices Regulations 2002 (Statutory Instrument 2002/618)
239:
Depending on the jurisdiction, custom-made medical devices can be
814:
Custom devices are subject to requirements including labelling (
566:
16:
Medical device intended for the sole use of a particular patient
909:. Ottawa, Ontario, Canada: Health Canada. 18 February 2016.
281:
clinical dental technicians/dental prosthetists/denturists
675:. Serious adverse incidents with medical devices must be
67:) (Canada, the European Union, the United Kingdom) or a
271:. Manufacturers of custom-made medical devices include
693:
Regulation (EU) 2017/745 (Medical Device Regulation )
325:
135:
Therapeutic Goods (Medical Devices) Regulations 2002
111:
964:(Section 520(b)). 11 December 2020. p. 425–426.
724:
International Organization for Standardization (ISO)
646:
that they are providing custom-made medical devices.
791:remains in line with EU law under the terms of the
769:
Medicines and Healthcare products Regulatory Agency
28:
23:
798:Custom-made devices are not required to carry the
755:Custom-made devices are not required to carry the
734:, the requirements of which are in alignment with
1011:. Therapeutic Goods Administration. November 2021
700:Directive 93/42/EEC (Medical Devices Directive )
213:Paragraph (1) shall apply to a device only if—
456:Dentofacial orthopaedic/functional appliances
8:
708:coronavirus disease 2019 (COVID-19) pandemic
936:
934:
882:
880:
873:(Regulations). Australia. 14 January 2022.
780:, during which EU law continued to apply.
608:Speech-language pathology/speech therapy
918:
916:
862:
147:Medical Devices Regulations SOR/98-282
976:"Custom-made devices in Great Britain"
888:Medical Devices Regulations SOR/98-282
20:
804:UK Conformity Assessed (UKCA) marking
7:
1122:PROTOCOL ON IRELAND/NORTHERN IRELAND
959:Federal Food, Drug, and Cosmetic Act
846:Marketed Health Products Directorate
793:Protocol on Ireland/Northern Ireland
227:Federal Food, Drug, and Cosmetic Act
41:
1127:. United Kingdom. 17 October 2019.
1110:. United Kingdom. 8 December 2020.
749:European Authorized Representative
14:
173:Medical Devices Regulations 2002
644:Therapeutic Goods Administration
265:medical practitioners/physicians
1093:. United Kingdom. 1 April 2019.
297:ocularists/orbital prosthetists
257:ocularists/orbital prosthetists
947:. United Kingdom. 20 May 2002.
521:Mandibular advancement splints
412:Oral and maxillofacial surgery
387:Oral and maxillofacial surgery
351:Oral and maxillofacial surgery
1:
1265:Regulation of medical devices
852:Medical Device Regulation Act
828:Food and Drug Administration
579:Palatal expansion appliances
59:, commonly referred to as a
1160:American football equipment
108:Definitions by jurisdiction
1301:
1190:European Union regulations
893:(Regulations). 7 May 1998.
824:quality systems regulation
778:implementation period (IP)
481:Hearing aid inserts/moulds
57:custom-made medical device
24:Custom-made medical device
1185:European Union directives
716:quality management system
42:
1058:10.1177/2050168420980980
628:Legislative requirements
309:orthopaedic shoe fitters
247:working within numerous
245:healthcare professionals
160:Regulation (EU) 2017/745
1255:Rehabilitation medicine
773:left the European Union
382:Craniofacial prostheses
1275:Rugby league equipment
1225:Orthodontic appliances
1210:Martial arts equipment
1165:Biomedical engineering
1046:Primary Dental Journal
732:risk management system
313:orthopedic technicians
253:hearing aid dispensers
85:orthodontic appliances
71:(United States), is a
1280:Rugby union equipment
1270:Restorative dentistry
1009:Australian Government
695:, which replaced and
555:Orthodontic retainers
449:Restorative dentistry
416:restorative dentistry
375:Restorative dentistry
567:Orthopaedic footwear
346:orthognathic surgery
1260:Rehabilitation team
1200:Implants (medicine)
671:/98-282) under the
615:Transpalatal arches
460:activator appliance
427:Dental restorations
330:Custom-made devices
249:medical specialties
1220:Medical technology
1205:Lacrosse equipment
673:Food and Drugs Act
293:dental technicians
251:such as dentists,
61:custom-made device
1230:Orthopedic braces
683:within 72 hours.
625:
624:
603:Speech prostheses
543:Ocular prostheses
537:Sports dentistry
468:Fränkel appliance
443:inlays and onlays
398:complete dentures
394:Dental prostheses
358:Auricular splints
335:Medical specialty
285:dental assistants
232:
231:
77:auricular splints
53:
52:
1292:
1285:Sports equipment
1245:Prosthodontology
1175:Dental equipment
1145:
1144:
1135:
1129:
1128:
1126:
1118:
1112:
1111:
1109:
1101:
1095:
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1041:
1035:
1034:
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920:
911:
910:
901:
895:
894:
892:
884:
875:
874:
867:
789:Northern Ireland
464:Clark twin block
402:partial dentures
342:Arch bars/wafers
326:
301:ophthalmologists
273:anaplastologists
210:(2) Limitations
112:
46:edit on Wikidata
38:
21:
1300:
1299:
1295:
1294:
1293:
1291:
1290:
1289:
1250:Protective gear
1235:Plastic surgery
1215:Medical devices
1150:
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1137:
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1120:
1119:
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869:
868:
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850:United States:
836:
812:
771:. Until the UK
765:
689:
665:
635:
630:
370:Bruxism splints
363:Plastic surgery
237:
181:(1) In general
166:United Kingdom
152:European Union
110:
101:
49:
34:
17:
12:
11:
5:
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1180:Ear procedures
1177:
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1152:
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1147:
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1130:
1113:
1096:
1079:
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848:
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840:Medical device
835:
832:
811:
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764:
763:United Kingdom
761:
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745:
742:
739:
727:
688:
687:European Union
685:
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569:
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529:
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526:Sleep medicine
523:
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483:
477:
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471:
452:
451:
446:
423:
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420:prosthodontics
409:
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366:
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360:
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344:to facilitate
338:
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178:United States
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73:medical device
51:
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26:
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15:
13:
10:
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2:
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1170:Biotechnology
1168:
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981:
980:UK Government
977:
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810:United States
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681:Health Canada
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548:Ophthalmology
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289:dental nurses
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70:
69:custom device
66:
62:
58:
47:
37:
33:
31:
27:
22:
19:
1195:Hearing aids
1139:
1133:
1116:
1099:
1082:
1052:(1): 64–88.
1049:
1045:
1039:
1025:
1013:. Retrieved
1008:
996:
984:. Retrieved
979:
970:
953:
905:
899:
865:
813:
797:
786:
782:
766:
754:
704:
690:
666:
636:
620:Orthodontics
596:Orthodontics
584:Orthodontics
560:Orthodontics
514:Orthodontics
502:Orthodontics
497:Lingual arch
474:Orthodontics
321:prosthetists
305:optometrists
295:, dentists,
277:audiologists
269:prosthetists
238:
221:
218:
215:
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206:
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185:
182:
123:Legislation
116:Jurisdiction
102:
68:
64:
60:
56:
54:
18:
1240:Prosthetics
818:Part 801),
642:Notify the
533:Mouthguards
243:by various
120:Definition
1154:Categories
1015:20 January
986:20 January
858:References
800:CE marking
757:CE marking
591:Quad helix
509:Lip bumper
406:obturators
317:orthotists
261:orthotists
241:prescribed
128:Australia
99:Definition
93:prostheses
1074:232245011
925:93/42/EEC
820:reporting
736:ISO 14971
720:ISO 13485
633:Australia
486:Audiology
89:orthotics
1066:33722134
844:Canada:
834:See also
697:repealed
677:reported
572:Orthoses
81:dentures
802:or the
722:, the
490:otology
439:veneers
435:bridges
140:Canada
36:D004864
1072:
1064:
816:21 CFR
663:Canada
431:crowns
1125:(PDF)
1108:(PDF)
1091:(PDF)
1070:S2CID
1005:(PDF)
962:(PDF)
945:(PDF)
891:(PDF)
235:Types
44:[
1062:PMID
1017:2022
988:2022
404:and
319:and
267:and
91:and
30:MeSH
1054:doi
679:to
669:SOR
65:CMD
1156::
1068:.
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1050:10
1048:.
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933:^
915:^
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488:/
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