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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ) article 53 CELEX: 02017R0746-20250110 Voluntary change of notified body
1. In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects: (a) the date on which the certificates issued by the outgoing notified body become invalid; (b) the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material; (c) the transfer of documents, including confidentiality aspects and property rights; (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body; (e) the last serial number or lot number for which the outgoing notified body is responsible. |
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ) article 53 CELEX: 02017R0746-20250110 2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid. |