Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

Clinical Evaluation of Software MDCG 2020-1

If the MDSW is used for the determination of a patient’s future state (e.g. predisposition, prognosis, prediction) or If the output of the MDSW impacts clinical outcomes (e.g. treatment efficacy) or patient management decisions, then a prospective study may be required as part of the device’s CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR)

The Organisation for Professionals in Regulatory Affairs

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Manufacturer's Documentation

Documentation

Classification

Article /Annex

Supporting Guidance

Clinical Development Plan

All Classifications

Annex XIV Part A (1) Annex XIV Part B

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Clinical Development Strategy (Expert panel) Clinical Evaluation Plan

Class III Class IIb*

Article 61 (2)

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All Classifications

Article 61 (1)

MDCG 2020-6 MEDDEV 2.7/1 Rev4

Clinical Evaluation Report (CER)

All Classifications

Article 61 (1) Annex IX Chapter II Annex XIV Part A

MEDDEV 2.7/1 Rev4** MDCG 2020-5 (Equivalence) MDCG 2020-6 (Legacy Devices)

PMCF Plan

All Classifications

Annex XIV Part B

MDCG 2020-7

PMS Plan

All Classifications

Article 84 Annex III (1.1)

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PMCF Evaluation Report

All Classifications

Article 61 (11) (12) Annex XIV Part B

MDCG 2020-8

Summary of Safety & Clinical Performance (SSCP)

Class III and Implantable Devices Class IIa, IIb and Class III Devices

Article 32

MDCG 2019-9

Periodic Safety Update Report (PSUR)

Article 86 Annex III (1.2)

In Progress^ ^ Expected Summer 2021

The Organisation for Professionals in Regulatory Affairs Clinical Evaluation Assessment Report (CEAR) is generated by the Notified Body based on the technical documentation provided. A copy is always sent to the Manufacturer. *= Class IIb devices designed to administer or remove a medical substance. ** = Sections 6.4, 8, 9, 10, A3, A4, A5, A6, A7.2, A7.3, A7.4, A10.

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