Table 1.

Overview of Main Legal Instruments Regulating Medical Products in the Respective Jurisdictions

Jurisdiction	Main legal instruments regulating medical products
United States	FD&C Act	Federal Food Drug & Cosmetics Act (FD&C Act) (Title 21 United States Code)
EU	MDR	Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 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, OJ L, 5.5.2017, p.1–175 (MDR)
	IVD Regulation	Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, OJ L 117, 5.5.2017, p.176–332 (IVD Regulation)
	Cell and Tissue Directive	Directive 2004/23/EC of the European Parliament and of the Council of March 31, 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells, OJ L 102, 7.4.2004, p.48–58 (Cell and Tissue Directive)
	ATMP Regulation	Regulation (EC) No 1394/2007 of the European Parliament and of the Council of November 13, 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, OJ l 324, 10.12.2007, p.121–137
	Medicinal Products for Human Use Directive	Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p.67–128
	EMA Regulation	Regulation (EC) No 726/2004 of the European Parliament and of the Council of March 31, 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p.1–70
Australia	The Act 1989	The Therapeutic Goods Act 1989 (Cth)
	Therapeutic Goods Regulation 1990	Therapeutic Goods Regulations 1990 (Cth)
	Medical Device Regulations 2002	Therapeutic Goods (Medical Devices) 2002 (Cth)

ATMP, Advanced Therapeutic Medicinal Product; EU, European Union.