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Comparison of the regulatory requirements for custom-made medical devices using 3D printing in Europe, the United States, and Australia

  • Ann-Kathrin Carl ORCID logo EMAIL logo and David Hochmann


Additive manufacturing (AM) has continuously grown in recent decades. Enhanced quality, further development of technology, and fall in prices make AM applicable and capable for various industrial applications, also for the manufacture of medical devices. 3D printing offers the possibility for an unprecedented adaptation to the anatomy of each patient, generating medical devices on a case-by-case basis. In many jurisdictions, custom-made devices qualify for an exemption to pre-market approval standards. This regulation is called into question by new technologies, like AM. Therefore, this article compares the current regulatory requirements for custom-made devices in Europe, the United States, and Australia and discusses the impact on 3D printed devices. It concludes that not all jurisdictions have yet adjusted their regulatory framework for custom-made devices to technological advances. Remaining uncertainties must be eliminated in order to help manufacturers comply with the regulatory requirements, emphasizing key aspects of AM.

Corresponding author: Ann-Kathrin Carl, Biomechatronics Research Laboratory, FH Münster University of Applied Sciences, Steinfurt, Germany, E-mail:

  1. Research funding: None declared.

  2. Author contribution: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.


1. Dykema, R. Printing for the perfect fit: balancing FDA regulation of 3D printed medical devices. Wis Law Rev 2019:593–622.Search in Google Scholar

2. Miller, A. The evolution of 3D printing: past, present and future; 2016. [cited 2021 May 3] Available from: in Google Scholar

3. Di Prima, M, Coburn, J, Hwang, D, Kelly, J, Khairuzzaman, A, Ricles, L. Additively manufactured medical products – the FDA perspective. 3D Print Med 2016;2:1. in Google Scholar

4. Horst, A, McDonald, F. Uncertain but not unregulated: medical product regulation in the light of three-dimensional printed medical products. 3D Print Addit Manuf 2020;7:248–57. in Google Scholar

5. International Medical Device Regulators Forum. Personalized medical devices – regulatory pathways: final document. 2020.Search in Google Scholar

6. McDonald, J. Regulatory considerations for devices manufactured using additive manufacturing technologies. In: Devine, DM, editor. Polymer-based additive manufacturing: biomedical applications. Cham: Springer; 2019:243–54 pp.10.1007/978-3-030-24532-0_11Search in Google Scholar

7. Therapeutic Goods Administration. Proposed regulatory changes related to personalised and 3D printed medical devices: consultation paper; 2017. Version 1.0.Search in Google Scholar

8. Morrison, RJ, Kashlan, KN, Flanangan, CL, Wright, JK, Green, GE, Hollister, SJ, et al.. Regulatory considerations in the design and manufacturing of implantable 3D-printed medical devices. Clin Transl Sci 2015;8:594–600. in Google Scholar

9. van Norman, GA. Expanded patient access to investigational new devices: review of emergency and Nonemergency expanded use, custom, and 3D-printed devices. JACC Basic Transl Sci 2018;3:533–44. in Google Scholar

10. Hoxey, E. New guidance on regulatory pathways for personalized medical devices; 2020. [cited 2021 April 12]. Available from: in Google Scholar

11. International Medical Device Regulators Forum. About IMDRF.Search in Google Scholar

12. International Medical Device Regulators Forum. Definitions for personalized medical devices: proposed document; 2018.Search in Google Scholar

13. 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: MDR.Search in Google Scholar

14. Dalgarno, K. The impact and potential for 3D printing and bioprinting in the medical devices industry; 2018. [cited 2022 January 6] Available from: in Google Scholar

15. McMorrow, D. Where do we stand with the new EU MDR, additive manufacturing, and customised medical devices? 2019. [cited 2021 April 6]. Available from: in Google Scholar

16. Handorn, B. Die Medizinprodukte-Verordnung (EU) 2017/745: Ein Leitfaden für Wirtschaftsakteure zur MDR, 1st ed. Berlin: Beuth; 2021.Search in Google Scholar

17. European Commission. Ref. ares(2017)4450987; 2017.Search in Google Scholar

18. European Federation of Laboratory Owners and Independent Dental Technicians. Dental technicians & medical device regulation; 2017.Search in Google Scholar

19. Heibach, M, Stock, G. 3D printing in the dental industry: position Paper of the Federation of the European Dental Industry (FIDE) on dealing with custom-made devices according to MDR; 2018. [cited 2021 May 4]. Available from: in Google Scholar

20. Unkelbach, L. Die Auswirkungen der EU-Medizinprodukte-Verordnung auf die Zahnarztpraxis. ZMK 2020;36.Search in Google Scholar

21. Deutsche Gesellschaft für interprofessionelle Hilfsmittelversorgung e.V. (DGIHV). Leitfaden: MDR - Hersteller von Hilfsmitteln als Sonderanfertigungen (Version 2.0). 2020.Search in Google Scholar

22. Medical Device Coordination Group. Questions and Answers on custom-made devices: & considerations on adaptable medical devices and patient-matched medical devices; 2021. [cited 2021 April 23] Available from: in Google Scholar

23. Willemsen, K, Nizak, R, Noordmans, HJ, Castelein, RM, Weinans, H, Kruyt, MC. Challenges in the design and regulatory approval of 3D-printed surgical implants: a two-case series. The Lancet Digital Health 2019;1:e163–71. in Google Scholar

24. BSI Group. MDR conformity assessment routes: notified body assessments; 2019. [cited 2022 January 6]. Available from: in Google Scholar

25. 94th U.S. Congress. Medical device amendments of 1976. Public Law; 1976:94–295 pp.Search in Google Scholar

26. Brennan, Z. FDA amends definition of custom device; 2016. [cited 2021 April 27]. Available from: in Google Scholar

27. Ivey, NS. Custom device exemption: webinar. [cited 2021 April 27]. Available from: in Google Scholar

28. Office of the Federal Register. Medical devices; custom devices; technical amendment: a rule by the food and drug administration on 10/12/2016; 2016.Search in Google Scholar

29. Mihalko, WM. How do I get what I need? Navigating the FDA’s custom, compassionate use, and HDE Pathways for medical devices and implants. J Arthroplasty 2015;30:919–22. in Google Scholar PubMed

30. U.S. Food and Drug Administration. Custom device exemption: guidance for industry and food and drug administration staff; 2014.Search in Google Scholar

31. U.S. Food and Drug Administration. Medical applications of 3D printing; 2017. [cited 2021 July 30]. Available from: in Google Scholar

32. Center for Devices and Radiological Health. Technical considerations for additive manufactured medical devices: guidance for industry and food and drug administration staff. FDA; 2017.Search in Google Scholar

33. Herr, T. Australia examines regulatory overhaul for personalized medical devices; 2020. [cited 2021 April 29] Available from: in Google Scholar

34. Therapeutic Goods Administration. Personalised medical devices (including 3D-printed devices): regulatory changes for custom-made medical devices; 2020. Version 2.0.Search in Google Scholar

35. Therapeutic Goods Administration. Personalised medical devices (including 3D-printed devices): regulatory changes for custom-made medical devices; 2021. Version 5.0.Search in Google Scholar

Received: 2021-08-16
Revised: 2022-01-10
Accepted: 2022-03-01
Published Online: 2022-03-16
Published in Print: 2022-04-26

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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