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Summary of Safety and Clinical Performance (SSCP)
Medical Devices and IVDsOctober 23, 2025

Summary of Safety and Clinical Performance (SSCP)

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7 SaMD Device Regulation (UK & Europe)
Medical Devices and IVDsOctober 23, 2025

7 SaMD Device Regulation (UK & Europe)

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Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023
Authorized RepresentativeOctober 22, 2025

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023

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MHRA Guidance on Stand-alone Software Medical Devices
Authorized RepresentativeOctober 22, 2025

MHRA Guidance on Stand-alone Software Medical Devices

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Article 61 Clinical Evaluation in the EU MDR
Authorized RepresentativeOctober 22, 2025

Article 61 Clinical Evaluation in the EU MDR

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The ‘Blue Guide’ on EU product rules implementation 2022
Authorized RepresentativeOctober 22, 2025

The ‘Blue Guide’ on EU product rules implementation 2022

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