To place on the market (or not)?
This article was originally published in RAJ Devices
Executive Summary
The definition of the term "placing on the market" is critical for medical device manufacturers whose products are marketed in the EU. It is in fact one of the core issues relating to the three EU medical device directives (the Medical Devices Directive – 93/42/EEC, the In Vitro Diagnostic Medical Devices Directive – 98/79/EC and the Active Implantable Medical Devices Directive – 90/385/EEC), which make the crucial acts of "placing on the market" and "putting into service" subject to compliance with the regulatory requirements under these directives.
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