Module 15 2022

5/19/2022

EUDAMED Database

EUDAMED

Available

• IT system for implementation of the MDR and IVDR • 6 modules and a public website:

• Actors registration

December 2020 October 2021 October 2021

• UDI/Devices registration

• Notified Bodies and Certificates

Under development Under development Under development

• Clinical Investigations and performance studies

• Vigilance and post-market surveillance

• Market Surveillance

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Classification

Classification

New Rules • Rule 11 software • Rule 19 nanomaterials

Based on risk and intended purpose

Class III

• Rule 20 administration by Inhalation • Rule 21 absorption/local dispersion • Rule 22 Active closed loop devices Changes • Devices containing active substances (Rule 14) • Up - classifications eg meshes spinal implants, devices in direct contact with the heart

Class IIb

High

Class IIa

Class I

Risk

sterile measuring resusable

Low

Class I

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