Chwilio Deddfwriaeth

Chwiliad Uwch

Regulation (EU) 2017/746 of the European Parliament and of the CouncilDangos y teitl llawn

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)

Help about what version

Pa Fersiwn

Help about UK-EU Regulation

Legislation originating from the EU

When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.

Close

Mae hon yn eitem o ddeddfwriaeth sy’n deillio o’r UE

Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE. EUR-Lex Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex. The EU Exit Web Archive legislation_originated_from_EU_p3

Status:

EU_status_warning_original_version
This legislation may since have been updated - see the latest available (revised) version

Article 81Periodic safety update report

1.Manufacturers of class C and class D devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:

(a)the conclusions of the benefit-risk determination;

(b)the main findings of the PMPF; and

(c)the volume of sales of the device and an estimate of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Manufacturers of class C and D devices shall update the PSUR at least annually. That PSUR shall be part of the technical documentation as specified in Annexes II and III.

2.Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87 to the notified body involved in the conformity assessment of such devices in accordance with Article 48. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system.

3.For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.

Yn ôl i’r brig

Options/Help

Print Options

You have chosen to open the Whole Regulation

The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open Schedules only

Y Rhestrau you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

Close

Mae deddfwriaeth ar gael mewn fersiynau gwahanol:

Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.

Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

Dewisiadau Agor

Dewisiadau gwahanol i agor deddfwriaeth er mwyn gweld rhagor o gynnwys ar y sgrin ar yr un pryd

Close

Rhagor o Adnoddau

Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:

  • y PDF print gwreiddiol y fel adopted version that was used for the EU Official Journal
  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • pob fformat o’r holl ddogfennau cysylltiedig
  • slipiau cywiro
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill
Close

Rhagor o Adnoddau

Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:

  • y PDF print gwreiddiol y fel adopted fersiwn a ddefnyddiwyd am y copi print
  • slipiau cywiro

liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys

  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • manylion rhoi grym a newid cyffredinol
  • pob fformat o’r holl ddogfennau cysylltiedig
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill