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)
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Version Superseded: 31/12/2020
Point in time view as at 05/04/2017.
There are currently no known outstanding effects by UK legislation for Regulation (EU) 2017/746 of the European Parliament and of the Council, Division 4.3..
The notified body shall require a formal application signed by a manufacturer or an authorised representative containing all of the information and the manufacturer's declarations required by the relevant conformity assessment as referred to in Annexes IX to XI.
The contract between a notified body and a manufacturer shall take the form of a written agreement signed by both parties. It shall be kept by the notified body. This contract shall have clear terms and conditions and contain obligations that enable the notified body to act as required under this Regulation, including an obligation on the manufacturer to inform the notified body of vigilance reports, the right of the notified body to suspend, restrict or withdraw certificates issued and the duty of the notified body to fulfil its information obligations.
The notified body shall have documented procedures to review applications, addressing:
the completeness of those applications with respect to the requirements of the relevant conformity assessment procedure, as referred to in the corresponding Annex, under which approval has been sought,
the verification of the qualification of products covered by those applications as devices and their respective classifications,
whether the conformity assessment procedures chosen by the applicant are applicable to the device in question under this Regulation,
the ability of the notified body to assess the application based on its designation, and
the availability of sufficient and appropriate resources.
The outcome of each review of an application shall be documented. Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 52 and shall be accessible to other notified bodies.
Mae’r holl gynnwys ar gael dan Drwydded Llywodraeth Agored v3.0 ac eithrio ble nodir yn wahanol. Yn ychwanegol mae’r safle hwn â chynnwys sy’n deillio o EUR-Lex, a ailddefnyddiwyd dan delerau Penderfyniad y Comisiwn 2011/833/EU ar ailddefnyddio dogfennau o sefydliadau’r UE. Am ragor o wybodaeth gweler ddatganiad cyhoeddus Swyddfa Gyhoeddiadau’r UE ar ailddefnyddio.
