notified body definition

notified body means a conformity assessment body designated in accordance with this Regulation;

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 a conformity assessment body authorised to carry out third-party conformity assessment tasks under Union law harmonising the conditions for the marketing of goods;

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 the certification organization designated by the relevant member state of the European Union, authorized to conduct conformity assessments in accordance with the procedures listed in the Directive.

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 a body authorised in accordance with Part V of the Medical Devices Directives to carry out tasks of a notified body or the importing Party under the Medical Devices Directives or the Mutual Recognition Agreements in respect of a conformity assessment procedure;