Module 19 2021

01/06/2021

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

01/06/2021

IVDeology Ltd | www.ivdeology.co.uk

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Device Registration Grace Period

01 Jan 2021 Devices for Performance Evaluation

30 June 2023 UKCA Marking Mandatory

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

01 May 2021 IVD Annex II List A

01 Jan 2022 General IVDs

26 May 2022 EU IVDR

01/06/2021

IVDeology Ltd | www.ivdeology.co.uk

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