https://orcid.org/0000-0003-4372-6584
References
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, 2017; [cited 2022 Mar 23]. Available from: https://eur-lex-europa-eu.ezproxy2.utwente.nl/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=IT#d1e1058-1-1.
- Martindale V, Menache A. The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks. J R Soc Med. 2013;106(5):173–177.
- Cohen D. Faulty hip implant shows up failings of EU regulation. Br Med J. 2012;345:e7163.
- Vasiljeva K, van Duren BH, Pandit H. Changing device regulations in the European union: impact on research, innovation and clinical practice. Indian J Orthop. 2020;54(2):123–129.
- Green JI. The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices. Br J Hosp Med. 2020;81(12):1–6.
- Green JIJ. Medical device regulation: requirements for dental professionals who prescribe and manufacture custom-made devices. Prim Dent J. 2021;10(1):64–88.
- CVZ. Procesbeschrijving Hulpmiddelenzorg. 2010.
- Heerkens Y, Bougie T, Claus E. The use of the ICF in the process of supplying assistive products: discussion paper based on the experience using a general dutch prescription guideline. Prosthet Orthot Int. 2011;35(3):310–317.
- CE Tool: Panton, Holland Innovative, Fris & Fruitig. 2022; [cited 2022 Apr 22]. Available from: https://cetool.nl/en.
- Questions and Answers on Custom-Made Devices. Medical Device Coordination Group. 2021; [cited 2022 Apr 22]. Available from: https://ec.europa.eu/health/system/files/2021-03/mdcg_2021-3_en_0.pdf.
- MDR requirements for custom-made medical devices: MDR Regulator; 2022; [cited 2022 Apr 22]. Available from: https://mdrregulator.com/news/custom-made-medical-devices-mdr.
- EUDAMED – European Database on Medical Devices. European Commission. 2021; [cited 2022 Mar 23]. Available from: ec.europa.eu/tools/eudamed.
- Personalised medical devices (including 3D-printed devices). 5 ed. Australia: Therapeutic Goods Administration. 2021. p. 32; [cited 2022 Apr 22]. Available from: https://www.tga.gov.au/sites/default/files/personalised-medical-devices-including-3d-printed-devices.pdf.
- ISO 13485 – Medical Devices – Quality management systems – requirements for regulatory purposes, 3 ed. International Organization for Standardization, Geneva, Switzerland, 2016; [cited 2022 Apr 22]. Available from: https://www.iso.org.