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Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.
↵i Directive 2001/95/EC
↵ii Directive 93/42/EEC; the same is true for the definition of ‘medical device’ in the Title 21 Code of Federal Regulations (CFR) Part 201(h)—both identify medical devices as those devices that are intended by the manufacturer to be used for treatment or diagnosis.
↵iii European Commission (2012), Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009.
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