Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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

The Organisation for Professionals in Regulatory Affairs

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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

• Deadline was 01 Jan 2022

The Organisation for Professionals in Regulatory Affairs

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