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 government agency, department or other authority to assess and certify the conformity of a medical device with the requirements of the EU legislation governing medical devices and with 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;
Examples of notified body in a sentence
Supplier will notify Customer promptly upon arrival of the Notified Body at Facility, provided that such Notified Body provides appropriate credentials and identifies Customer and the Product.
Each Unannounced Audit by a Notified Body shall be deemed an Additional Audit and is subject to [***].
Because Supplier is Customer’s Critical Subcontractor or Crucial Supplier, Medical M▇▇▇▇▇ will accept and support Unannounced Audits by a Notified Body, solely to the extent applicable to Customer information in Supplier custody and control within the scope of such audit.
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 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 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 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.
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.