notified body means a conformity assessment body authorised to carry out third-party conformity assessment tasks under Union law harmonising the conditions for the marketing of goods;
notified body means an entity licensed, authorized or approved by the applicable Governmental Authority to assess and certify the conformity of a medical device with the requirements of the EU Medical Devices Directive and applicable harmonized standards.
Examples of notified body in a sentence
A Regulatory Approval includes a device approval application such as, with respect to the European Union, a submission to a Notified Body for the performance of a conformity assessment.
More Definitions of notified body
notified body means a conformity assessment body designated in accordance with this Regulation and other relevant Union harmonisation legislation;
notified body means a conformity assessment body notified in accordance with Chapter IX of this Regulation;
notified body means a conformity assessment body notified in accordance with Article 22 of this Regulation;
notified body means an organization designated by the competent national administration of a Member State in accordance with Article 9;
notified body means a conformity assessment body designated in accordance with Article 33 of this Regulation and other relevant Union harmonisation legislation;
notified body means an entity licensed, authorized or approved by the applicable Governmental Authority to assess and certify the conformity of a medical device with the requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended from time to time, and applicable harmonized standards.
notified body means an entity licensed, authorized or approved by the applicable government agency, department or other authority to assess and certify the conformity of a medical device with the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 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 concerning medical devices, as amended from time to time, and applicable harmonized standards.