6. Regulatory context

Despite the potential of additive manufacturing in the medical field, there are many regulatory and safety hurdles to overcome . In order to bring the product to market, the device must meet specific standards to ensure that it does not represent a risk to the patient . Standards are generally very strict, and have a direct impact on the global medical implant market.

Indeed, while...

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Regulatory context

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Discussion and conclusions

Bibliography

(1) - HORN (T.J.), HARRYSSON (O.L.A.) - Overview of current additive manufacturing technologies and selected applications. - Science Progress (2012).
(2) - BARCLIFT (M.W.), WILLIAMS (C.B.) - Examining variability in the mechanical...

Standards and norms

D11 Committee: Test Method for Rubber Property – Durometer Hardness, ASTM International - ASTM - 2017
Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56041), ASTM International - ASTM F136-08 - 2014
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants...

Regulations

EU 2017/745 – Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning 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 (2017)