Version detected , Modified +11 −10§
no amending act named
Explanation, written by a model and checked against the cited text
In the definition of manufacturer, the phrase describing marketing under the manufacturer's own identifier changes from "trademark" to "trade mark", a purely formal spelling change with no substantive difference in meaning.
Cited: Art. 2, v1 (external, EUR-Lex) · Art. 2, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version 32017R0745 → this version, detected 12 August 2026 02017R0745-20170505
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for … 1,258 unchanged words … market for the first time for its intended purpose;
(30) manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark; trade mark;
(31) fully refurbishing, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it … 1,364 unchanged words … of Article 2 of Regulation (EU) No 1025/2012;
(71) common specifications (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.