Module 16 2024

21/10/2024

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.

PMCF-study

Internal and external customer surveys for product feedback

Conferences, mainly trade shows Customer surveys

user feedback via training programs

Feedback from users about the performance of the scalpel and the use of the scalpel

Information from conferences, congresses, commercial exhibitions

Implant registries

User feedback during training

PMCF-studies

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

Type of data

Required for class III/ implantibles

1 2 3 4

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

5 Equivalence

+ PMS/PMCF

6 State of the art *Similar devices 7 Complaints and vigilance

Not clinical data * Supportive for WET devices

8 Proactive PMS such as that derived from surveys 9 Individual case reports

Low quality clinical data supportive

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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