Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

So how do I demonstrate ‘State of the Art’?

International Guidance or National Guidance (EU) Documents

European Medical Societies/National Medical Organisations

Literature Searches

PMS Data – Non-Inferior Model (Statistical analysis)

Physician Surveys/Usage Data

Real World Evidence e.g. Registry Data

The Organisation for Professionals in Regulatory Affairs

27

Clinical Evidence – MDCG 2020-6

Evidence Source

1 2

High Quality Clinical Investigations

Legacy class III devices and implantable devices

Medium Quality Clinical Investigations

High Quality Registry Data 3 Justifiable Studies with some Methodological flaws/ High Quality Surveys 4 5 Equivalence Data (Reliable/Quantifiable) 6 Evaluation for State of The Art/Similar Device Evidence (WET Article 52) Complaints, Vigilance. 7 Proactive PMS data such as surveys 8 Case Reports/Studies 9

10

Compliance to Non-Clinical Specifications

Not clinical

Animal study data 11 Pre-clinical/Bench Testing/Compliance to Non-Clinical Standards 12

The Organisation for Professionals in Regulatory Affairs

28

14