CE marking of conformity definition

CE marking of conformity or ‘CE marking’ means a marking by which the manufacturer indicates that the device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;
CE marking of conformity. (CE marking) means a marking by which a provider indicates that an AI system is in conformity with the requirements set out in Title III, Chapter 2 of this Regulation and other applicable Union legislation harmonising the conditions for the marketing of products (‘Union harmonisation legislation’) providing for its affixing;
CE marking of conformity means a marking by which the manufacturer indicates that the EHR system is in conformity with the applicable requirements set out in this Regulation and other applicable Union legislation providing for its affixing pursuant to Regulation (EC) No 765/2008;

Examples of CE marking of conformity in a sentence

  • Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex IV.

  • Invigilators may inspect any materials or items in the examination room, or in any student's possession, at any time during the examination.

  • Where the compliance of the AI systems with the requirements set out in Chapter 2 of this Title has been demonstrated following that conformity assessment, the providers shall draw up an EU declaration of conformity in accordance with Article 48 and affix the CE marking of conformity in accordance with Article 49.

  • Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20.

  • Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.


More Definitions of CE marking of conformity

CE marking of conformity. (CE marking) means a marking by which a provider indicates that an AI system is in conformity with the requirements set out in Title III, Chapter 2 or in Article 4b of this Regulation and other applicable Union legal act harmonising the
CE marking of conformity or “CE marking” means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Part and with any other applicable legislation;
CE marking of conformity means a marking by which the manufacturer indicates that the EHR system is in conformity with the applicable
CE marking of conformity or 'CE marking' means a marking by which the manufacturer indicates that the device is in conformity with the applicable
CE marking of conformity means a marking by which the manufacturer
CE marking of conformity or “CE marking” means a marking by which the manufacturer indicates that a medical device is inconformity with the applicable
CE marking of conformity means a marking by which the manufacturer indicates that the EHR system is in conformity with the applicable requirements set out in this Regulation and other applicable Union legislation providing for its affixing pursuant to Regulation (EC) No 765/2008 of the European Parliament and of the Council29;