Module 18 2021

2/9/2021

Types of Clinical Evidence – Pre Clinical

• Bench Testing • Compliance to Non Clinical Standards • Animal Studies

Pre-Clinical is NOT ‘Clinical Data’ Remember Article 2 (48)!

Suitable for Article 61 (10) route to conformity.

May support ‘Clinical Data’ or Equivalence Claims.

31

Copyright © 2020 BSI. All rights reserved

31

Clinical Evidence – MDCG 2020-6 Evidence Source

1 High Quality Clinical Investigations 2 Medium Quality Clinical Investigations 3 High Quality Registry Data 4 Justifiable Studies with some Methodological flaws/ High Quality Surveys 5 Equivalence Data (Reliable/Quantifiable) 6 Evaluation for State of The Art/Similar Device Evidence (WET Article 52) 7 Complaints, Vigilance. 8 Proactive PMS data such as surveys 9 Case Reports/Studies 10 Compliance to Non- Clinical Specifications 11 Animal study data 12 Pre-clinical/Bench Testing/Compliance to Non-Clinical Standards

32

Copyright © 2020 BSI. All rights reserved

32

16