The Medical Devices Introductory Course 2020

Identifying data sources

Three key sources of data: 1. Studies published in medical journals and identified by searching scientific databases 2. Unpublished, internal data 3. Complaint/post-market surveillance data • National registries • Safety databases (FDA’s MAUDE, MHRA...)

Other sources may also be used (e.g. Google Scholar)

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Documents/information typically needed

Materials/components

Product accessories

Usability studies

CE Mark Number and date of CE marking

Preclinical data (e.g. test reports)

UDI

EMDN (and other relevant codes)

Previous CER(s)

Marketing claims

Relevant GSPRs

Previous Literature Reviews Customer Feedback Data

Regulatory History

Registry data

Physician Feedback Data

Applicable standards/ common specifications

PMS plans

Equivalence documentation

Internal complaints and sales data

Search Terms

PMS Reports/PSURs

Instructions for Use

Risk management file

Incidence reports

Completed/planned PMCF studies

Other product labelling

Clinical investigations

Type and duration of contact

Biological Evaluation Report Device classification

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