Module 16 2022

9/2/2022

Relevant Guidance

CEN ISO/TR 20416:2020 – Annex C examples of PMS Plans

• Examples of proactive data collection

Surgical Scalpel (Class I)

Radiation Therapy System (Class IIb)

Drug Eluting Stent (Class III)

Contact with actual users, during training, sales meetings etc. Conferences, mainly trade shows Feedback from users about the performance of the scalpel and the use of the scalpel

PMCF-study

Internal and external customer surveys for product feedback user feedback via training programs

Customer surveys

Information from conferences, congresses, commercial exhibitions

Implant registries

User feedback during training PMCF-studies

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Hierarchy of Clinical Data

MDCG 2020-6 Legacy Devices: Hierarchy of Clinical Data Types

Type of data

Required for class III/ implantables

1 2 3 4

High quality clinical studies High quality clinical studies (gaps) Registries Clinical studies with flaws

5 Equivalence 6 State of the art *Similar devices 7 Complaints and vigilance 8 Proactive PMS such as that derived from surveys

+ PMS/PMCF

Not clinical data * Supportive for WET devices

Low quality clinical data supportive

9 Individual case reports 10 Common specifications

Not clinical data

11 Simulated use/animal/cadaver testing by user 12 Pre-clinical/bench/compliance to standards

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