Module 19 2021

01/06/2021

EUDAMED Modules

Public site – Information available from day 1 Identities of Economic Operators and Sponsors, (Basic) UDI-DIs and limited datasets of devices

Medical device nomenclature codes and their descriptions • The list of Notified Bodies designated under the MDR and IVDR

Issued and refused CE Marking certificates Summaries of safety and clinical performance Applications and notifications for clinical investigations or performance studies Reported adverse events and device deficiencies Summaries of clinical investigations or performance studies before devices are placed on the market Final Field Safety Notices/FSCAs Summary Reports of Member States’ market surveillance activities

01/06/2021

IVDeology Ltd | www.ivdeology.co.uk

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UKCA Device Registration Timelines

All devices must be registered on the MHRA Database by the legal manufacturer or the UKRP if applicable

Annex II List A devices 01 May 2021

Annex II List B and self test devices 01 September 2021

General Self-Declared 01 January 2022

01/06/2021

IVDeology Ltd | www.ivdeology.co.uk

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