Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Device Uploads

 Once establishment has been added to the database, devices can be uploaded and linked to the Manufacturer  Any additions, or changes to device registration will be subject to £100 fee  Mass upload function is available, using excel mass upload spreadsheet  There is no accreditation, certification or approval. CE marking requires Declaration of Conformity from the manufacturer  Make sure that the device name is identical to the information in the Declaration of Conformity

The Organisation for Professionals in Regulatory Affairs

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Device Registration Grace Period

01 Jan 2021 Devices for Performance Evaluation

01 May 2021 IVD Annex II List A

01 Sep 2021 IVD Annex II List B IVD Self-Tests

30 June 2024 UKCA Marking Mandatory

01 Jan 2022 General IVDs

21 Oct 2022 Official extension of deadline

26 May 2022 EU IVDR

The Organisation for Professionals in Regulatory Affairs

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